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Daytime and nitetime - Medication Information

Product NDC Code 51013-124
Drug Name

Daytime and nitetime

Type Brand
Dosage Form KIT
RxCUI drug identifier 1086997,
1094549,
2634564
Application Number part341
Labeler Name PuraCap Pharmaceutical LLC
Packages
Package NDC Code Description
51013-124-02 1 kit in 1 carton (51013-124-02) * 1 blister pack in 1 carton / 8 capsule, liquid filled in 1 blister pack * 1 blister pack in 1 carton / 4 capsule, liquid filled in 1 blister pack
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Overdosage of DayTime and NiteTime

Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.
Overdose warning Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each softgel) Active ingredients for DayTime (in each Softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Active ingredients for NiteTime (in each Softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Take only as directed - see Overdose warning swallow whole; do not crush, chew, or dissolve do not exceed 4 doses per 24 hours Age DayTime NiteTime adults and children 12 years of age and over take 2 softgels with water every 4 hours take 2 softgels with water every 6 hours children 4 to under 12 years of age ask a doctor ask a doctor children under 4 years of age do not use do not use When using other DayTime or NiteTime products, carefully read each label to ensure correct dosing
Age DayTime NiteTime
adults and children 12 years of age and over take 2 softgels with water every 4 hours take 2 softgels with water every 6 hours
children 4 to under 12 years of age ask a doctor ask a doctor
children under 4 years of age do not use do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients NiteTime: D&C yellow # 10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink DayTime: FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses temporarily relieves common cold/flu symptoms: nasal congestion (DayTime only) cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing (NiteTime only)

Purpose

Information about the drug product’s indications for use.
Purpose DayTime Liquid Capsules Pain reliever/fever reducer Cough suppressant Nasal decongestant NiteTime Liquid Capsules Pain reliever/fever reducer Cough suppressant Antihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
DayTime and NiteTime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride DayTime acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL clear oblong PC9 NiteTime acetaminophen, dextromethorphan hydrobromide, doxylamine succinate ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN DOXYLAMINE SUCCINATE DOXYLAMINE D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL clear oblong PC10

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel ASSURED DayTime and NiteTime Liquid Capsules Combo Pack 12 count NDC 51013-124-02 *Compare to the active ingredients in VICKS® DayQuil® and NyQuil® Cold and Flu LiquiCaps® Carton Label

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you have liver disease heart disease (DayTime only) thyroid disease (DayTime only) diabetes (DayTime only) high blood pressure (DayTime only) trouble urinating due to an enlarged prostate gland cough that occurs with excessive phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema, and (for NiteTime only) chronic bronchitis glaucoma (NiteTime only)

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (NiteTime only)

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep (NiteTime only)

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call toll free: 1-855-215-8180

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if you get nervous, dizzy, or sleepless (DayTime only) pain, cough and (for DayTime only) nasal congestion gets worse or last more than 7 days redness or swelling is present fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product When using this product, do not use more than directed. In addition, when using NiteTime: excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Liver warning These products contain acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Sore throat warning If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep (NiteTime only) Ask a doctor before use if you have liver disease heart disease (DayTime only) thyroid disease (DayTime only) diabetes (DayTime only) high blood pressure (DayTime only) trouble urinating due to an enlarged prostate gland cough that occurs with excessive phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, or emphysema, and (for NiteTime only) chronic bronchitis glaucoma (NiteTime only) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (NiteTime only) When using this product When using this product, do not use more than directed. In addition, when using NiteTime: excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness Stop use and ask a doctor if you get nervous, dizzy, or sleepless (DayTime only) pain, cough and (for DayTime only) nasal congestion gets worse or last more than 7 days redness or swelling is present fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API