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 Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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 tablets 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 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 of overdose, 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 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
  
• children under 12 years: do not use
  

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

PRINCIPAL DISPLAY PANEL

Acetaminophen 500mg Tablet

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63629-1516(NDC:57896-201)
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)
STEARIC ACID (UNII: 4ELV7Z65AP)
CROSPOVIDONE (UNII: 68401960MK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	ROUND (Round)	Size	12mm
Flavor		Imprint Code	M2A457344
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63629-1516-1	20 in 1 BOTTLE
2	NDC: 63629-1516-2	15 in 1 BOTTLE
3	NDC: 63629-1516-3	40 in 1 BOTTLE
4	NDC: 63629-1516-4	100 in 1 BOTTLE
5	NDC: 63629-1516-5	30 in 1 BOTTLE
6	NDC: 63629-1516-6	45 in 1 BOTTLE
7	NDC: 63629-1516-7	50 in 1 BOTTLE
8	NDC: 63629-1516-8	60 in 1 BOTTLE
9	NDC: 63629-1516-9	90 in 1 BOTTLE
10	NDC: 63629-1516-0	250 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	01/01/1989

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(63629-1516) , RELABEL(63629-1516)