FDA Label for Acetaminophen 500mg Diphenhydramine Hcl 25mg
View Indications, Usage & Precautions
Acetaminophen 500mg Diphenhydramine Hcl 25mg 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 500mg; Diphenhydramine 25mg
Inactive Ingredient
colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, hydroxypropyl methyl cellulose, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Dosage & Administration
- take with a full glass of water
- do not take more than directed
- do not take more than 2 caplets in 24 hours
- 2 caplets at bedtime
- do not take more than 2 caplets in 24 hours
adults and children 12 years of age and over | |
children under 12 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 4000mg of acetaminophen in 24 hours
- 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
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- if youhave ever had an allergic reaction to this product or any of its ingredients
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostrate gland
- glaucoma
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- drowsiness will occur
- avoi alcoholic drinks
- do not drive a motor vehicle or operate machinery
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
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.
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
Nighttime sleep-aid
Other Safety Information
- store at room temperature between 20 °C - 25 °C (68 °F - 77 °F)
Package Label.Principal Display Panel
* Please review the disclaimer below.