EXTRA STRENGHTH ACETAMINOPHEN- acetaminophen tablet

Extra Strenghth Acetaminophen by

Drug Labeling and Warnings

Extra Strenghth Acetaminophen by is a Otc medication manufactured, distributed, or labeled by OPMX, Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each tablet)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

Temporary relieves minor aches and pains due to:

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

Warnings

Liver warning:This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3000 mg) 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

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.

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

Colloidal silicon dioxide, pregelatinized starch, povidone (pvp k-30), croscarmellose sodium, potassium sorbate, stearic acid

Questions or Comments

Call 619-600-5632 Monday through Friday 9AM-5PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGHTH ACETAMINOPHEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-107
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	AP500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-107-40	1 in 1 CARTON	07/31/2017
1		40 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	07/31/2017

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
Health Pharma USA LLC		080804485	manufacture(69729-107)