ADULTS ACETAMINOPHEN AND CAFFEINE PAIN RELIEVER FEVER REDUCER- acetaminophen, caffeine tablet

Adults Acetaminophen and Caffeine Pain Reliever Fever Reducer by

Drug Labeling and Warnings

Adults Acetaminophen and Caffeine Pain Reliever Fever Reducer by is a Otc medication manufactured, distributed, or labeled by Genvion Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 500mg

Caffeine 65mg

Purpose

Pain Reliever- Fever Reducer

Analgesic Adjuvant

Uses

• For the temporary relief of minor aches and pains associated with headache and to reduce 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 for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

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.

for more than 10 days for pain unless directed by a doctor

for more than 3 days for fever unless directed by a doctor

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

new symptoms 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.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Take 1 tablet every 3-4 hours, while symptoms persist, or as directed by a doctor

Do not exceed 8 tablets in 24 hours

Children under 12 years of age: consult a doctor

Other information

store at room temperature (59-86°F/15-30°C

do not use if inner mouth seal is broken

Inactive ingredients

Colloidal Silicon Dioxide, Cornstarch, Ethylparaben, FD&C Red No. 40, FD&C Yellow No. 6, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol, Povidone, Pregelatinized Starch, Propylparaben, Sodium Carboxymethyl Starch, Sodium Starch Glycolate, Stearic Acid, Sucralose, Talc, Titanium Dioxide

Package Labeling:

INGREDIENTS AND APPEARANCE

ADULTS ACETAMINOPHEN AND CAFFEINE PAIN RELIEVER FEVER REDUCER 
acetaminophen, caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62049-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
ETHYLPARABEN (UNII: 14255EXE39)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	104
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62049-002-00	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	05/05/2016

Labeler - Genvion Corporation (245221226)