EXTRA STRENGTH PAIN RELIEF- acetaminophen capsule, gelatin coated

Extra Strength Pain Relief by

Drug Labeling and Warnings

Extra Strength Pain Relief by is a Otc medication manufactured, distributed, or labeled by Geri-Care Pharmaceutical Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each gelcap)

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 gelcaps 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.

Keep out of reach of children

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.

Directions

• Do not take more than directed
• Adults and children 12 years and over: take 2 gelcaps every 4-6 hours, as needed. Do not take more than 8 gelcaps 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)
• avoid high humidity

Inactive Ingredients

Croscarmellose Sodium, D and C Red 33, FD and C Blue 1, FD and C Red 40, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide, PEG, Povidone, Propylene Glycol, Shellac Glaze, Starch, Stearic Acid, Titanium Dioxide.

Package label

Gericare

NDC: 57896-251-01

Non-aspirin

Extra Strength

PAIN RELIEF

Pain Reliever / Fever Reducer

Compare to active ingredient in Tylenol Extra Strength Rapid Release gels

ACETAMINOPHEN

Rapid Release Gels

100 Gelcaps

500 mg each

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF 
acetaminophen capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57896-251
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	red (red, gray and blue)	Score	no score
Shape	CAPSULE (Gelcap)	Size	19mm
Flavor		Imprint Code	L5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57896-251-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	06/01/2007

Labeler - Geri-Care Pharmaceutical Corp (611196254)

Registrant - Geri-Care Pharmaceutical Corp (611196254)