Otc - Active Ingredient
Acetaminophen 500mg; Diphenhydramine 25mg
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc for the product Acetaminophen 500mg Diphenhydramine Hcl 25mg (NDC 70692-119). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, otc - purpose, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 500mg; Diphenhydramine 25mg
colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
| adults and children 12 years of age and over |
|
| children under 12 years of age | do not use |
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
Allergy alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
if a skin reaction occurs, stop use and seek medical help right away
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.
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.
Pain reliever
Nighttime sleep-aid
* Please review the disclaimer below.