EXTRA STRENGTH PAIN RELIEVER- acetaminophen, aspirin, caffeine tablet, coated

Extra Strength Pain Reliever by

Drug Labeling and Warnings

Extra Strength Pain Reliever 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 ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain Reliever

Pain reliever aid

Use

• temporarily relieves minor aches and pains

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use

this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these

symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (wheezing)

shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than directed

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher

if you

are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

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

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you are taking a diuretic

you have asthma

Ask a doctor or pharmacist before use if you are taking

any other drug containing an NSAID (prescription or nonprescription)

a blood thinning (anticoagulant) or steroid drug

a prescription drug for diabetes, gout, or arthritis

any other drug, or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.

you experience any of the following signs of stomach bleeding:

• feel faint vomit blood
• have bloody or black stools
• have stomach pain that does not get better

ringing in the ears or loss of hearing occurs

painful area is red or swollen

pain gets worse or lasts for more than 10 days

fever gets worse or lasts more than 3 days

any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use. It is especially important not

to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor

because it may cause problems in the unborn child or complications during delivery.

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 use more than directed (see overdose warning)

drink a full glass of water with each dose

adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours

children under 12: ask a doctor

Other Information

• store at controlled room temperature 15° - 25°C (59°-77°F)
• read all product information before using

Inactive ingredients

cellulose, fractionated coconut oil, hypromellose, magnesium silicate, maltodextrin, polydextrose, povidone, silica, starch, stearic acid, titanium dioxide.

Package label

NDC: 68016-110-00

*Compare to the active ingredients in Excedrin

Premier Value

Extra Strength

PAIN RELIEVER

Acetaminophen 250mg

Aspirin 250mg

Caffeine 65mg

100 Caplets

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH PAIN RELIEVER 
acetaminophen, aspirin, caffeine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-110
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
POVIDONE (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	white (WHITE)	Score	no score
Shape	CAPSULE (Capsule)	Size	17mm
Flavor		Imprint Code	GC226
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-110-00	1 in 1 CARTON	04/01/2008
1		100 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	04/01/2008

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(68016-110)