HEADACHE PAIN RELIEVER- acetaminophen, aspirin and caffeine tablet, film coated

HEADACHE PAIN RELIEVER by

Drug Labeling and Warnings

HEADACHE 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

USES

• temporarily relieves minor aches and pains

WARNINGS

REYE'S SYNDROME:

Children and teenages 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 eary sign of Reye's syndrome, a rare but serious illnes.

ALLERY ALERT

Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (sheezing)

shock

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 usng 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 (anticogulant) or steroid drug

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

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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.

DO NOT USE

Do not use

• if you have ever had an allergic reaction to acetaminophen, 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 for 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

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

INACTIVE INGREDIENTS

carnauba wax, cellulose,
hypromellose, mineral oil, povidone, silica, sodium starch
glycolate, starch, stearic acid, titanium dioxide

Other information

• store at room temperature 15°- 25°C (59°- 77°F)

Package label

INGREDIENTS AND APPEARANCE

HEADACHE PAIN RELIEVER 
acetaminophen, aspirin and caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-231
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
STEARIC ACID (UNII: 4ELV7Z65AP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE (CAPSULE SHAPED TABLET)	Size	18mm
Flavor		Imprint Code	TCL370
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-231-00	1 in 1 CARTON	07/01/2015
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	07/01/2015

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(68016-231)