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severe cold and flu relief drug information

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Rite Aid Corporation · ORAL

Product NDC: 11822-4099

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Generic nameACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Labeler / manufacturerRite Aid Corporation
RouteORAL
Drug classDrug class not supplied in source label
Product NDC11822-4099
Label effective date2026-09-09

Official product label reference

severe cold and flu relief — Rite Aid Corporation

This page contains 15 source sections for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, oral route. Label set 4b8ae971-ab57-4937-a878-72d905d7b849, version 4.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • cough to help you sleep • minor aches and pains • headache • sore throat • fever • runny nose and sneezing • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant
Dosage and administration — label text
Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use Table text from source: | adults & children 12 yrs & over | 30 mL every 4 hrs | children 6 to under 12 yrs | 15 mL every 4 hrs | children 4 to under 6 yrs | ask a doctor | children under 4 yrs | do not use
Warnings
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 3 or more alcoholic drinks every day 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. 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 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. • if you have ever had an allergic reaction to this product or any of its ingredients • to make a child sleepy Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • glaucoma • thyroid disease • diabetes • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers When using this product • do not use more than directed • 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 • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • 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: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Active ingredient
Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg Phenylephrine HCl 5 mg
Do not use
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. • if you have ever had an allergic reaction to this product or any of its ingredients • to make a child sleepy
Ask a doctor before use
Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • glaucoma • thyroid disease • diabetes • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin • taking sedatives or tranquilizers
While using this medicine
When using this product • do not use more than directed • 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
When to stop use and seek help
Stop use and ask a doctor if • you get nervous, dizzy or sleepless • pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults) • 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.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other safety information
Other information • each 15 mL contains: sodium 15 mg • store at 20-25°C (68-77°F)
Inactive ingredient
Inactive ingredients anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum
Questions
Questions? 1-800-719-9260

Official sources and product identifiers

Substances listed: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE

RxNorm identifiers: 1431245

Package NDC codes

11822-4099-0

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.