Pain reliefes tablet

Active ingredient

Acetaminophen 500 mg

Purpose

Analgesic/Antipyretic

Uses

temporary relief of minor aches and pains associated with common cold headache toothache
muscular aches backache arthritis menstrual cramps and reduction of fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 8 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

Ask doctor

Ask a doctor before use if you haveliver disease

Ask doctor/pharmacist

Ask a doctor or pharmacist before use if youare taking the blood thinning drug warfarin

Stop use

Stop use and ask a doctor if symptoms do not improve pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling
is present a rare sensitivity reaction occurs You may report side effects to 1-888-952-0050

Pregnancy or breast feeding

If pregnant or breast-feeding , ask a health professional before use

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt 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

Adults and children 12 years of age and older:Take 2 caplets every 4 to 6 hours as needed. Do not take more than 8 caplets in 24 hours

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 room temperature
do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

corn starch, pregelatinized starch, stearic acid. May contain povidone and sodium starch glycolates.

Ingredients and appearance - Product information

Pain reliefes tablet- Acetaminophen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 62211-012
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 500 mgin 1

Inactive Ingredients

Ingredient Name Code
Starch, corn ( UNII: O8232NY3SJ)
Hypromellose 2208 (100 mpa.s) ( UNII: B1QE5P712K)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Stearic acid ( UNII: 4ELV7Z65AP)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE Size 17 mm
Shape CAPSULE Score 1
Imprint Code AZ012

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part343 USA

Labeler - A&Z Pharmaceutical, Inc.( 926820705)

Establishment

Name ID/FEI Business Operations
A&Z Pharmaceutical, Inc. 926820705 ANALYSIS( 62211-012), MANUFACTURE( 62211-012), LABEL( 62211-012), PACK( 62211-012), RELABEL( 62211-012), REPACK( 62211-012)

Package/label principal display panel