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Maximum strength congestion and headache - Medication Information

Product NDC Code 0363-9019
Drug Name

Maximum strength congestion and headache

Type Brand
Pharm Class Adrenergic alpha1-Agonists [MoA],
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
Phenylephrine hydrochloride 5 mg/1
Route ORAL
Dosage Form CAPSULE, LIQUID FILLED
RxCUI drug identifier 1086997
Application Number M012
Labeler Name Walgreens
Packages
Package NDC Code Description
0363-9019-16 2 blister pack in 1 carton (0363-9019-16) / 8 capsule, liquid filled in 1 blister pack
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients (in each liquid gel) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant
Active ingredients (in each liquid gel)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal 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 do not take more than directed (see Overdose warning ) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and older: take 2 softgels every 4 hours children under 12 years of age: do not use

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients FD&C Red# 40, FD&C Yellow# 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

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 these common cold and flu symptoms: nasal congestion cough headache minor aches and pains sinus congestion and pressure temporarily reduces fever temporarily promotes nasal and/or sinus drainage

Purpose

Information about the drug product’s indications for use.
Active ingredients (in each liquid gel) Purposes Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant
Active ingredients (in each liquid gel)Purposes
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Spl product data elements

Usually a list of ingredients in a drug product.
Maximum Strength Congestion and Headache Acetaminophen, Dextromethorphan hydrobromide, and Phenylephrine hydrochloride FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL 400 POVIDONE K30 PROPYLENE GLYCOL SORBITOL SORBITAN TITANIUM DIOXIDE WATER ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE Orange to Red OBLONG 512;A09

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 MAXIMUM STRENGTH CONGESTION & HEADACHE Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Phenylephrine HCl – Nasal Decongestant Relieves Headache & Fever Controls Cough Relieves Nasal Congestion 16 SOFTGELS CCF

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.
Drug Facts

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 diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)

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 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.

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? 1-888-333-9792

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 nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days 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 do not use more than directed

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 20-25°C (68-77°F) 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 This product contains acetaminophen. Severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. 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. Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse or lasts more than 7 days 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 (overdose) may cause liver damage. 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