Time-gesic
FDA Label NDC 49483-356

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Time-cap Labs, Inc for the product Time-gesic (NDC 49483-356). 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 otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Do Not Use

Do 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.

Otc - Ask Doctor

Ask a doctor before use if you have liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Otc - Stop Use

Stop use and ask a doctor if

pain persists for more than 10 days; fever persists for more than 3 days (unless directed by a doctor); condition worsens or new symptoms appear; redness or swelling is present. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or nursing, as with any drug, seek the advise of a health professional before using this product.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of reach of children.

Dosage & Administration

Directions
adults and children 12 years and over: take 1 to 2 tablets every six hours while symptoms last. Maximum daily dose is 9 tablets in 24 hours unless directed by a doctor.

children under 12 years: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

Storage And Handling

Other information

  • store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F)
  • use by expiration date on package
  • avoid excessive heat
  • sodium free

Inactive Ingredient

colloidal silicon dioxide, crospovidone, fd&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid

Indications & Usage

Uses: temporarily releives mnor aches and pains due to:

headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual cramps.

Otc - Purpose

Pain Reliever-fever reducer-antihistamine

Warnings

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult or child 12 years and older takes more than 12 tablets in 24 hours, which is the maximum daily amount; taking with other durgs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product.

Otc - Active Ingredient

Each tablet contains:

acetaminophen 325 mg

diphenhydramine HCl 12.5 mg

Package Label.Principal Display Panel

356r Label (356rlabel)

356r Label (356rlabel)

* Please review the disclaimer below.