EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet

Extra Strength Pain Relief by

Drug Labeling and Warnings

Extra Strength Pain Relief by is a Otc medication manufactured, distributed, or labeled by NuCare Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

• temporarily relieves minor aches and pains
  
• temporarily reduces 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). Ifyou 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

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptom 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.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case ofoverdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Keep out of reach of children.

Directions

• do not take more than directed
• adults and children 12 years and over: take 1-2 caplets every 4-6 hours, as needed; not more than 8 caplets in 24 hours
  
• children under 12 years: ask a doctor

Other Information

• TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
• store at 20⁰C-25⁰C (68⁰F-77⁰F)
• for institutional use only

Inactive ingredients

povidone, sodium starch glycolate, starch stearic acid. May also contain: crospovidone, methylparaben and probylparaben

Package label

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68071-3050(NDC:57896-221)
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
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	CAPSULE (Capsule)	Size	15mm
Flavor		Imprint Code	M2A457344
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68071-3050-2	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2017
2	NDC: 68071-3050-4	45 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2017
3	NDC: 68071-3050-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2017
4	NDC: 68071-3050-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/01/1989

Labeler - NuCare Pharmaceuticals, Inc. (010632300)

Establishment
Name	Address	ID/FEI	Business Operations
NuCare Pharmaceuticals, Inc.		010632300	repack(68071-3050)