CETAFEN- acetaminophen tablet

CETAFEN by

Drug Labeling and Warnings

CETAFEN by is a Otc medication manufactured, distributed, or labeled by HART Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (in each tablet): Acetaminophen 325mg

PURPOSE

Pain Reliever/Fever Reducer

INDICATIONS & USAGE

Uses:

Temporarily relieves minor aches and pains due to:

• headache
• muscular aches
• backache
• minor arthritis pain
• the common cold
• toothache
• menstrual cramps

Temporarily reduces fever

WARNINGS

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours
• 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
• rash
• blisters

DO NOT USE

Do not use with any other drug containing acetaminophen (prescription or non-prescription)

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if:

• you are taking the blood thinning drug warfarin
• you do not know if other drugs you are taking contain acetaminophen

ASK DOCTOR

Ask a doctor before use if you have liver disease

STOP USE

Stop use and ask a doctor if:

• an allergic reaction occurs, seek medical help right away
• new symptoms occur
• redness or swelling is present
• fever worsens or lasts for more than 3 days
• pain worsens or lasts for more than 10 days

These could be signs of a serious condition

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

OVERDOSAGE

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact Poison Control Center right away. 1-800-222-1222

DOSAGE & ADMINISTRATION

Directions:

Do not take more than directed.

Adults and children 12 year of age and over:

• take 2 tables every 4 to 6 hours while symptoms persist
• do not take more than 8 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Corn Starch, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Stearic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETAFEN 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	CFN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0103-4	50 in 1 BOX, UNIT-DOSE	06/04/1986
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0103-7	125 in 1 BOX, UNIT-DOSE	06/04/1986
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 50332-0103-8	250 in 1 BOX, UNIT-DOSE	06/04/1986
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 50332-0103-1	500 in 1 BOX, UNIT-DOSE	06/04/1986
4		2 in 1 PACKET; 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	06/04/1986

Labeler - HART Health (069560969)