Extra Strength Mapap: Package Insert and Label Information

EXTRA STRENGTH MAPAP- acetaminophen tablet
Aidarex Pharmaceuticals 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 500 mg

Purposes

Pain Reliever/Fever Reducer

Aspirin Free Extra Strength Pain Reliever

Uses

for the temporary relief of minor aches and pains due to:

• •headache
• •muscular aches
• •backache
• •minor pain of arthritis
• •the common cold
• •toothache
• •premenstrual and menstrual cramps
• •temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen.

The maximum daily dose of this product is 6 tablets (3,000mg) in 24 hours. 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

Do not use

• •with any other drug containing acetaminophen (prescription or non prescription). 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

This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In the 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 the directed (see overdose warning)

Adults and children 12 years and over:

• •Take 2 tablets every 6 hours while symptoms last.
• •Do not take more than 6 tablets in 24 hours unless directed by a doctor
• •Do not take for more than 10 days unless directed by a doctor

Children under 12 years: Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

• •Store at room temperature

Inactive ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions or comments?

To report Adverse Drug Event call (800) 616-2471

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Repackaged By:

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

Principal Display Panel

NDC 0904-1988-59

See New Warnings Information and Directions

EXTRA STRENGTH

Mapap TABLETS

ASPIRIN FREE

STRONG PAIN AND FEVER RELIEF

Mapap ES 500mg tablet

EXTRA STRENGTH MAPAP acetaminophen tablet

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33261-003(NDC:0904-1988) 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 POVIDONE, UNSPECIFIED STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID

Product Characteristics Color WHITE Score 2 pieces Shape ROUND (round flat faced beveled edge) Size 12mm Flavor Imprint Code GPI;A5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:33261-003-00 100 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:33261-003-20 20 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:33261-003-30 30 TABLET in 1 BOTTLE, PLASTIC None 4 NDC:33261-003-40 40 TABLET in 1 BOTTLE, PLASTIC None 5 NDC:33261-003-45 45 TABLET in 1 BOTTLE, PLASTIC None 6 NDC:33261-003-50 50 TABLET in 1 BOTTLE, PLASTIC None 7 NDC:33261-003-60 60 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/04/2011

Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 08/2017 Aidarex Pharmaceuticals LLC