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

Manufacturer: Genvion Corporation
Effective date: 2019-12-16
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 23:51:17

Label at a glance#

ProductAdults Acetaminophen and Caffeine Pain Reliever Fever Reducer

Active ingredientACETAMINOPHEN, CAFFEINE

Label structure7 sections

Indications and uses

For the temporary relief of minor aches and pains associated with headache and to reduce fever.

Dosage and administration

• 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

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

Caffeine 65mg

Purpose

OTC - PURPOSE SECTION

Pain Reliever- Fever Reducer

Analgesic Adjuvant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with headache and to reduce fever.

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

• new symptoms occur • redness or swelling is present. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

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

• do not use if inner mouth seal is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Adults Acetaminophen and Caffeine Pain Reliever Fever Reducer
ACETAMINOPHEN, CAFFEINE
SILICON DIOXIDE
STARCH, CORN
ETHYLPARABEN
FD&C RED NO. 40
FD&C YELLOW NO. 6
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
PROPYLPARABEN
STEARIC ACID
SUCRALOSE
TALC
TITANIUM DIOXIDE
ACETAMINOPHEN
CAFFEINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62049-002	62049-002-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
ETHYLPARABEN	14255EXE39	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
CAFFEINE	3G6A5W338E	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c18648db-e057-33eb-e053-2995a90a72f7			bdfcbc9b-3eeb-4a68-ab97-88bfa9bbb876	2021-05-04	Warnings	Exact identifier spl set id: bdfcbc9b-3eeb-4a68-ab97-88bfa9bbb876

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.