Acetaminophen And Diphenhydramine Hydrochloride
FDA Label NDC 65437-041

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Himprit Pharmachem Pvt Ltd for the product Acetaminophen And Diphenhydramine Hydrochloride (NDC 65437-041). 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 other, otc - purpose, uses, alcohol warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each Caplet)Purpose
Acetaminophen 500 mgPain reliever/ fever reducer
Diphenhydramine HCL 25 mgSleep 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"

Principal Display Panel 500/25 mg Shipper Label (Acetaminophen 01)

Principal Display Panel 500/25 mg Shipper Label (Acetaminophen 01)

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