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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Adult's Acetaminophen and Caffeine Pain Reliever - Fever Reducer Tablets

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:

Label

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Genvion Corporation (245221226)

Revised: 5/2021

Document Id: c18648db-e057-33eb-e053-2995a90a72f7

Set id: bdfcbc9b-3eeb-4a68-ab97-88bfa9bbb876

Version: 4

Effective Time: 20210504

Genvion Corporation