FDA Label for Acetaminophen And Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- LIVER WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 24 CAPLET BOTTLE CARTON
Acetaminophen And Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product J.p. Business Enterprise. 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.
Other
Drug Facts
Distributed By: J.P Business Enterprise Lake Grove, NY 11755
Otc - Purpose
Active ingredients (in each caplet) | Purpose |
---|---|
Acetaminophen 500mg | Pain reliever |
Diphenhydramine HCl 25mg | Nighttime Sleep aid |
Uses
for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Liver Warning
This product contains acetaminophen. Severe liver damage may occur with this product if you take
- more than 2 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while you are using this product
Do Not Use
- with other products containing acetaminophen (prescription or nonprescription).
- in children under 12 years of age
- with any other products containing diphenhydramine, even one used on skin
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
Ask A Doctor Before Use If You Have
- liver cirrhosis
- asthma
- breathing problems such as emphysema or chronic bronchitis
- trouble in urinating due to an enlargement of the prostate gland
- glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
- 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 more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick 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 recommended (see overdose warning)
- take 2 caplets at bedtime or as directed by a doctor
- do not take more than 2 caplets in a 24 hour period
- do not use this adult product in children under 12 years of age. This will provide more than the recommended dose (overdose) and may cause liver damage
adults and children 12 years of age and over: | |
children under 12 years or age: |
Other Information
- store at 20°-25°C (68°-77°F)
- see end panel for lot number and expiration
- each tablet contains: magnesium 0.05 mg
Inactive Ingredients
FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, pregelatinized starch, povidone, stearic acid, titanium dioxide
Questions Or Comments?
1-888-333-9792
Principal Display Panel - 24 Caplet Bottle Carton
VALUMEDS
SEE NEW WARNINGS INFORMATION
Compare to the active ingredients
in
TYLENOL
® PM
*
EXTRA STRENGTH
PAIN RELIEF PM
PAIN RELIEVER • NIGHTTIME SLEEP AID
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
24 CAPLETS
* Please review the disclaimer below.