OTC Medication Information: Extra Strenghth Acetaminophen

EXTRA STRENGHTH ACETAMINOPHEN- acetaminophen tablet
Health Pharma USA LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

(in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

  • temporary relieves minor aches and pains due to
  • the common cold
  • headache
  • backache
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps and
  • temporarily reduces fever

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 have ever had an allergic reaction to this product or any of its ingredients

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: Taking more than the reccomended dose (overdose) may cause liver damage. In case of overdose. get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.

Directions

  • do not use more than directed (see overdose warning)
  • Adults and children 12 years of age and older:
  • Take 2 caplets every 6 hours while symptoms last.
  • Do not take more than 6 caplets in 24 hours, unless directed by a doctor
  • Do not use more than 10 days unless directed by a doctor.
  • Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

Other Information

  • store at controlled room temperature 20-25°C (68-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive Ingredients

Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Polyethylene Glycol, Polyvinyl Pyrolidone, Stearic Acid, Talc, Titanium Dioxide

Questions or Comments

1-844-832-1138 (Mon-Fri 9AM-5PM EST) or www.healthlifeofusa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

* This product is not manufactured or distributed by McNeil-Consumer Healthcare, owner of the registered trademark Tylenol*.

apap 500
(click image for full-size original)

EXTRA STRENGHTH ACETAMINOPHEN
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71679-031
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, PREGELATINIZED CORN
POVIDONE, UNSPECIFIED
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
HYPROMELLOSES
CARNAUBA WAX
STEARIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
MINERAL OIL
Product Characteristics
Color white Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code AP500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71679-031-00 1 BAG in 1 BOX contains a BAG
1 29090 TABLET in 1 BAG This package is contained within the BOX (71679-031-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 07/31/2017
Labeler — Health Pharma USA LLC (080804485)
Establishment
Name Address ID/FEI Operations
Health Pharma USA LLC 080804485 manufacture (71679-031)

Revised: 11/2022 Health Pharma USA LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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