EXTRA STRENGTH PAIN RELIEF- acetaminophen tablet, coated

Extra Strength Pain Relief by

Drug Labeling and Warnings

Extra Strength Pain Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, Geri-Care Pharmaceutical Corp. 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 due to:
• - headache
• - muscular aches
• - backache
• - arthritis
• - the common cold
• - toothache
• - menstrual cramps

• 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.

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 (see overdose warnings)
  • 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 controlled room temperature 20⁰C-25⁰C (68⁰F-77⁰F)
• avoid high humidity

Inactive Ingredients

croscarmellose sodium, D&C Red #33, FD&C Blue #1, FD&C Red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide, PEG, povidone, propylene glycol, shellac glaze, starch, stearic acid, titanium dioxide.

package label

NDC: 68016-029-47

Compare to active ingredient in Extra Strength Tylenol Rapid Release Gels*

Extra Strength

PAIN RELIEF

ACETAMINOPHEN

Rapid Release

Pain Reliever/ Fever Reducer

Gelcaps

400 Gelcaps

500 mg each

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEF 
acetaminophen tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-029
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)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	red (with blue and a gray band)	Score	no score
Shape	CAPSULE (Gelcap)	Size	19mm
Flavor		Imprint Code	L;5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-029-20	1 in 1 CARTON	09/01/2007
1		100 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 68016-029-14	1 in 1 CARTON	09/01/2007
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 68016-029-47	400 in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/01/2007

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - Geri-Care Pharmaceutical Corp (611196254)

Establishment
Name	Address	ID/FEI	Business Operations
Geri-Care Pharmaceutical Corp		611196254	repack(68016-029)