FDA Label for Acetaminophen Diphenhydramine Hcl
View Indications, Usage & Precautions
- ACTIVE INGRIDIENTS
- PURPOSES
- USES
- LIVER WARNING
- ALLERGY ALERT
- DSO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGRIDIENTS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Acetaminophen Diphenhydramine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Granules Usa, 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.
Active Ingridients
(in each caplet)
Acetaminophen, USP 500mg
Diphenhydramine HCl. 25mg
Purposes
Pain reliever
Nighttime sleep-aid
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Liver Warning
This product containsacetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while
using this product
Allergy Alert
acetaminophen may cause severs skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away
Dso Not Use
■ with any other drug containing acetaminophen (prescription or nonprescription). 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 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
■ a breathing problem such as emphysema or chronic brochitis
■ trouble urinating due to an enlarged prostate gland
■ glaucoma
Ask A Doctor Or Pharmacist Before Use If You Have
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
When Using This Product
■ drowsiness will occur
■ avoid alcoholic drinks
■ do not drive a motor vehicle or operate machinery
Stop Use And Ask A Doctor If
■ sleeplessness persists continuously for morethan 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
■ pain gets worse or lasts more t han 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
■ do not take more than directed (see overdose warning)
adults andchildren 12 years and over
■ take 2 caplets at bedtime do not use
■ do not take more than 2 caplets of this product in 24 hours
children under 12 years
■ do not use
Other Information
■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature.
■ see end panel for expiration date and lot number
Inactive Ingridients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate, povidone,pregelatinized starch, stearic acid, titanium dioxide
Package Label.Principal Display Panel
* Please review the disclaimer below.