Acetaminophen-apap 8 Hour
FDA Label NDC 41520-336

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Acetaminophen-apap 8 Hour (NDC 41520-336). 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 active ingredient (in each caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Caplet)

Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • headache
    • minor pain of arthritis
    • backache
      • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 caplets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask A Doctor Before Use If You Have

Liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are

Taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

  • pain gets worse or lasts 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.

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children.

Overdose warning: 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 directed (see overdose warning)
    adults and children 12 years and over ▪ take 2 caplets every 8 hours with water
    ▪ swallow whole - do not crush, chew, split or dissolve
    ▪ do not take more than 6 caplets in 24 hours
    ▪ do not use for more than 10 days unless directed by a doctor
    children under 12 years ▪ do not use

Other Information

  • store at 20 - 25° C (68 - 77° F). Avoid excessive heat 40° C (104° F).
  • see end panel for batch number and expiration date
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

Inactive Ingredients

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

Questions?

Call 1-888-423-0139

Principal Display Panel

Compare to the Active Ingredient in Tylenol®8 Hour**

CAREONE®

Use only as directed.

Lasts up to 8 HOUR

PAIN RELIEF

Acetaminophen Extended-Release Tablets, USP 650 mg

PAIN RELIEVER · FEVER REDUCER

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

For Up To 8 Hour Relief of Minor Muscle Aches & Pain

24 CAPLETS*650 mg Each

*Capsule-Shaped Tablets

DISTRIBUTED BY: AMERICAN SALES COMPANY

5089223/R0811

This Is The 24 Count Blister Carton Label For Careone Acetaminophen Extended-release Tablets, Usp 650 mg (8 Hour). (Apap8hour)

This Is The 24 Count Blister Carton Label For Careone Acetaminophen Extended-release Tablets, Usp 650 mg (8 Hour). (Apap8hour)

* Please review the disclaimer below.