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Antigrip daytime - Medication Information

Product NDC Code 55758-381
Drug Name

Antigrip daytime

Type Brand
Pharm Class Adrenergic alpha1-Agonists [MoA],
Decreased Respiratory Secretion Viscosity [PE],
Expectorant [EPC],
Increased Respiratory Secretions [PE],
Sigma-1 Agonist [EPC],
Sigma-1 Receptor Agonists [MoA],
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],
Uncompetitive NMDA Receptor Antagonists [MoA],
alpha-1 Adrenergic Agonist [EPC]
Active Ingredients
Acetaminophen 325 mg/1
Dextromethorphan hydrobromide 10 mg/1
Guaifenesin 200 mg/1
Phenylephrine hydrochloride 5 mg/1
Route ORAL
Dosage Form POWDER, FOR SOLUTION
RxCUI drug identifier 2677915
Application Number M012
Labeler Name Pharmadel LLC
Packages
Package NDC Code Description
55758-381-18 18 pouch in 1 carton (55758-381-18) / 1 powder, for solution in 1 pouch (55758-381-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients & Purposes Active ingredients (in each packet) Purposes Acetaminophen 325 mg………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 10 mg…………………………... Cough suppressant Guaifenesin 200 mg ..................................... Expectorant Phenylephrine HCL 5 mg…….………………………….. Nasal decongestant
Active ingredients (in each packet)Purposes
Acetaminophen 325 mg…………………………………Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg…………………………...Cough suppressant
Guaifenesin 200 mg .....................................Expectorant
Phenylephrine HCL 5 mg…….…………………………..Nasal decongestant

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 dissolve one packet in an 8oz. glass of hot water. If using a microwave; add content into a glass of cool water and stir briskly before and after heating. Do not overheat. sip while hot and consume the entire drink within 10-15 minutes Age Dose adults and children 12 years of age and over one (1) packet every 4 hours, take every 4 hours; do not exceed 6 packets in a 24 hours children under 12 years of age do not use
AgeDose
adults and children 12 years of age and overone (1) packet every 4 hours, take every 4 hours; do not exceed 6 packets in a 24 hours
children under 12 years of agedo not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, chamomile honey flavors, isopropyl alcohol, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate, water

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 Temporary relieves common cold/flu symptoms: minor aches and pains sore throat headache stuffy nose nasal congestion cough due to minor throat and bronchial irritation and temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Purpose

Information about the drug product’s indications for use.
Active ingredients (in each packet) Purposes Acetaminophen 325 mg………………………………… Pain reliever/ fever reducer Dextromethorphan HBr 10 mg…………………………... Cough suppressant Guaifenesin 200 mg ..................................... Expectorant Phenylephrine HCL 5 mg…….………………………….. Nasal decongestant
Active ingredients (in each packet)Purposes
Acetaminophen 325 mg…………………………………Pain reliever/ fever reducer
Dextromethorphan HBr 10 mg…………………………...Cough suppressant
Guaifenesin 200 mg .....................................Expectorant
Phenylephrine HCL 5 mg…….…………………………..Nasal decongestant

Spl product data elements

Usually a list of ingredients in a drug product.
ANTIGRIP Daytime Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL ANHYDROUS CITRIC ACID SILICON DIOXIDE ISOPROPYL ALCOHOL MALTODEXTRIN WATER GUAIFENESIN GUAIFENESIN ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN ACESULFAME POTASSIUM ACESULFAME ASPARTAME SODIUM CITRATE SUCROSE PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE TRIBASIC CALCIUM PHOSPHATE Chamomile - Honey

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 Antigrip Day CH PDP

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drugs Facts Other information each packet contains: potassium 10 mg, sodium 27 mg phenylketonurics: contains phenylalanine 13 mg per packet store at room temperature 68-77°F (20-25°C) do not use if packet is punctured or torn Dist. by: PHARMADEL LLC New Castle, DE, 19720

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 high blood pressure thyroid disease diabetes glaucoma a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema difficulty urinating due to an enlarged prostate gland

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

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 prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 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

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. In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions & comments? 1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

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 doctor if nervousness, dizziness, or sleeplessness occurs redness or swelling is present pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days any new symptoms occur a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. 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 do not exceed recommended dosage

Pregnancy or breast feeding

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

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: This product contains acetaminophen . Severe liver damage may occur if you take more than 6 packets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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 prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or 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 Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema difficulty urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dosage Stop use and ask doctor if nervousness, dizziness, or sleeplessness occurs redness or swelling is present pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days any new symptoms occur a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. 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. In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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