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.
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 55106-9
Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
Section 60561-8
- store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
- avoid excessive heat and humidity
Structured Label Content
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 |
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.
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 55106-9 (55106-9)
Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
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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Source: dailymed · Ingested: 2026-02-15T11:59:03.232059 · Updated: 2026-03-14T22:58:52.562418