PAIN RELIEFEXTRA STRENGTH EXTRA STRENGTH- acetaminophen 500 mg tablet

Pain ReliefExtra Strength by

Drug Labeling and Warnings

Pain ReliefExtra Strength by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

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 takemore than 4000 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

■ if you are allergic to acetaminophen   ■ 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 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

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

If pregnant or breast-feeding

ask a health professional before use

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

■ 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

If you are 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

■ do not use more than directed (see overdose warning)
■ adults and children 12 years and over: take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.
■  do not use more than 10 days unless directed by a doctor
■ children under 12 years: do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Overdose warning: Taking more than the recommended 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.

Inactive Ingredients

corn starch, hydroxypropyl methylcellulose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide.
May contain povidone, and sodium starch glycolate.

Package/Label Principal Display Panel

Health A2Z®                    Compare to Tylenol® active ingredient*

See New Warnings Information

Extra Strength
PAIN RELIEF
500mg
Acetaminophen

Pain Reliever-Fever Reducer
CONTAINS NO ASPIRIN

50 Tablets

Health A2Z 235

 

Label 235

      

INGREDIENTS AND APPEARANCE

PAIN RELIEFEXTRA STRENGTH  EXTRA STRENGTH
acetaminophen 500 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-235
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, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	AZ235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-235-05	50 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 NOT FINAL	part343	12/17/2014

Labeler - Allegiant Health (079501930)