acetaminophen, dextromethorphan and phenylephrine day time cold and flu
563452d1-0c19-4094-895a-805c859bc49b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
pain reliever Cough Suppressant Nasal decongestant
Description
(in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Medication Information
Warnings
Warnings Failure to follow these warnings could result in serious consequences.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours which is maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
do not use:
- with any other drug containing acetaminophen (prescription or not prescription). 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
- Thyroid disease
- Diabetes
- High blood pressure
- Trouble urinating due to enlarged prostate gland
-
ask your 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:
- Redness or swelling is present
- You get nervous, dizzy or sleepless
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Symptoms do not get better within 7 days or are accompanied by a fever
Uses
pain reliever, cough suppressant and Nasal decongestant
Purpose
pain reliever
Cough Suppressant
Nasal decongestant
Other Information
- store at room temperature
Inactive Ingredients
FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide
Description
(in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg
Direction
- do not exceed 4 doses per 24 hours
- take only as directed – see overdose warning
- Adults and children 12 years and over: 2 softgels with water every 4 hours
- children under 12 years: ask a doctor
- Children under 4 years: do not use
Active Ingredient
(in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Questions Or Comments
Call toll free 1-855-314-1850
Keep Out of Reach of Children.
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of 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.
Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.
Package Label.principal Display Panel
NDC: 58805-002-14 , 58805-002-08
Structured Label Content
Warnings
Warnings Failure to follow these warnings could result in serious consequences.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours which is maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
do not use:
- with any other drug containing acetaminophen (prescription or not prescription). 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
- Thyroid disease
- Diabetes
- High blood pressure
- Trouble urinating due to enlarged prostate gland
-
ask your 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:
- Redness or swelling is present
- You get nervous, dizzy or sleepless
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Symptoms do not get better within 7 days or are accompanied by a fever
Uses
pain reliever, cough suppressant and Nasal decongestant
Purpose
pain reliever
Cough Suppressant
Nasal decongestant
Other Information
- store at room temperature
Inactive Ingredients
FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide
Direction
- do not exceed 4 doses per 24 hours
- take only as directed – see overdose warning
- Adults and children 12 years and over: 2 softgels with water every 4 hours
- children under 12 years: ask a doctor
- Children under 4 years: do not use
Active Ingredient
(in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Questions Or Comments (Questions or Comments)
Call toll free 1-855-314-1850
Keep Out of Reach of Children. (Keep out of reach of children.)
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. In case of 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.
Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
NDC: 58805-002-14 , 58805-002-08
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:53.516971 · Updated: 2026-03-14T22:53:55.198203