FDA Label for Acetaminophen And Diphenhydramine Hydrochloride
View Indications, Usage & Precautions
Acetaminophen And Diphenhydramine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Himprit Pharmachem Pvt Ltd. 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
Otc - Purpose
| Active ingredients (in each Caplet) | Purpose |
|---|---|
| Acetaminophen 500 mg | Pain reliever/ fever reducer |
| Diphenhydramine HCL 25 mg | Sleep Aid |
Uses
Temporary relief of occasional headaches and minor aches and pain with accompanying sleeplessness
Alcohol Warnings
If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
Do Not Use
* with any other product containing acetaminophen* with any other product containing diphenhydramine, even one used on skin* in children under 12 years of age
Otc - Ask Doctor
Ask a doctor before use if you have
* a breathing problem such as emphysema or chronic bronchitis* glaucoma* difficulty in urination due to enlargement of the prostate gland
Otc - Ask Doctor/Pharmacist
ASK a doctor or pharmacists before use if you are taking sedatives or tranquilizers
Otc - When Using
When using this product
* do not exceed recommended dosage* avoid alcoholic beverages* marked drowsiness may occur* do not drive a motor vehicle or operate machinery
Otc - Stop Use
Stop use and ask a doctor if
* sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness* new symptoms occur* redness or swelling is present* pain gets worse or lasts more than 10 days* fever gets worse or lasts more than 3 days
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. 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.
Direction
* use as directed* adults and children 12 years and over : take 2 caplets at bedtime or as directed by a doctor* Children under 12 years : do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.
Other Information
* Store at room temperature
Inactive Ingredients
croscarmellose sodium, hypromellose, polythlene glycol,sodium metabisulfate, stearic acid,, sodium starch glycolate,collodial silicon dioxide, FD & C blue # 1
Principal Display Panel 500/25 Mg Shipper Label
ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLETS
Each Film coated Tablet Contains:
ACETAMEINOPHEN 500 mg
DIPHENHYDRAMINE HCL 25 mg
Lot No :
MFG. DATE :
Exp. Date :
Jar No. :
Quantity : 31000 Tablets
NDC. No : 65437-041-31
WARNING :
KEEP OUT OF THE REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPRATURE OF 59° –86°F (15° – 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE FDA AND REGULATIONS THEREUNDER
MANUFACTURED BY:
MANUFACTURED CODE No Guj/Drugs/G/1362
LABELER CODE # 14803
MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT. LTD
"LAKULISH", R.V.DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA – 390 001
CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"
* Please review the disclaimer below.