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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Available from:
Genvion Corporation
INN (International Name):
ACETAMINOPHEN
Composition:
ACETAMINOPHEN 500 mg
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- For the temporary relief of minor aches and pains associated with headache and to reduce fever.
Authorization status:
OTC monograph not final
Authorization number:
62049-002-00

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

Purpos e

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:

ADULTS ACETAMINOPHEN AND CAFFEINE PAIN RELIEVER FEVER

REDUCER

acetaminophen, caffeine tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 20 49 -0 0 2

Route of Administration

ORAL

Genvion Corporation

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

50 0 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

STARCH, CO RN (UNII: O8 232NY3SJ)

ETHYLPARABEN (UNII: 14255EXE39 )

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

re d

S core

no sco re

S hap e

ROUND

S iz e

12mm

Flavor

Imprint Code

10 4

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 20 49 -0 0 2-0 0

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 5/20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 5/0 5/20 16

Labeler -

Genvion Corporation (245221226)

Revised: 12/2019

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