cold & flu - gripa (acetaminophen 325mg; dextromethorphan hbr 10mg, guaifenesin 200mg, phenylephrine hcl 5mg)
9239bf18-0e2b-20d5-e053-2a95a90addc8
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
Medication Information
Warnings and Precautions
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 caplets 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
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 non 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 ths product
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostrate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthama, chronic bronchitis, or emphysema
Ask a doctor or a 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
- you get nervous, dizzy or sleepless
- 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: In case of 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.
Active Ingredient
Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
Indications and Usage
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness
Dosage and Administration
- take with a full glass of water
- do not take more than directed
- do not exceed 8 caplets per 24 hours
| adults & children 12 years of age & over | 2 caplets with water every 4 hours |
| children 4 to 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
Description
Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
Section 50565-1
Keep out of reach of children
Overdose Warning: In case of 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.
Section 51727-6
colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow#6, magnesium staerate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, stearic acid, talc
Section 51945-4
Section 55105-1
Pain reliever / fever reducer, cough suppressant, expectorant, nasal decongestant
Section 60561-8
- store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
- avoid excessive heat and humidity
Structured Label Content
Warnings and Precautions (34071-1)
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 caplets 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
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 non 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 ths product
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostrate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthama, chronic bronchitis, or emphysema
Ask a doctor or a 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
- you get nervous, dizzy or sleepless
- 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: In case of 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.
Active Ingredient (55106-9)
Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
Indications and Usage (34067-9)
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness
Dosage and Administration (34068-7)
- take with a full glass of water
- do not take more than directed
- do not exceed 8 caplets per 24 hours
| adults & children 12 years of age & over | 2 caplets with water every 4 hours |
| children 4 to 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
Section 50565-1 (50565-1)
Keep out of reach of children
Overdose Warning: In case of 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.
Section 51727-6 (51727-6)
colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow#6, magnesium staerate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, stearic acid, talc
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Pain reliever / fever reducer, cough suppressant, expectorant, nasal decongestant
Section 60561-8 (60561-8)
- store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
- avoid excessive heat and humidity
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:59:03.232059 · Updated: 2026-03-14T22:58:52.562418