FDA Label for Acetaminophen 500mg, Dextromethorphan Hbr 10mg, Guaifenesin 200mg, Phenylephrine Hcl 5mg
View Indications, Usage & Precautions
Acetaminophen 500mg, Dextromethorphan Hbr 10mg, Guaifenesin 200mg, Phenylephrine Hcl 5mg Product Label
The following document was submitted to the FDA by the labeler of this product Strive Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
Inactive Ingredient
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
Dosage & 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 |
Indications & Usage
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness
Warnings
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
- skin reddening
- blisters
- rash
- 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
- 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
- taking the blood thinning drug warfarin
- do not use more than directed
- 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
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
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
Ask a doctor before use if you have
Ask a doctor or a pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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.
Otc - Keep Out Of Reach Of Children
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.
Otc - Purpose
Pain reliever / fever reducer, cough suppressant, expectorant, nasal decongestant
Other Safety Information
- store at room temperature between 20 °C - 25 °C (68 °F - 77 °F)
- avoid excessive heat and humidity
Package Label.Principal Display Panel
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