CETAFEN EXTRA- acetaminophen tablet

CETAFEN EXTRA by

Drug Labeling and Warnings

CETAFEN EXTRA 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 caplet): Acetaminophen 500mg

PURPOSE

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 symptms occur
• redness or swelling is present
• fever worsens or lasts more than 3 days
• pain worsens or lasts 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 a Poison Control Center right away. 1-800-222-1222.

DOSAGE & ADMINISTRATION

Directions:

Do not take more than directed

Adults and children 12 years of age and over:

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

Children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information:

• caplets enclosed in a sealed packet
• do not use if packet is torn, cut or open
• store at 59° to 86°F (15°-30°C)
• avoid excessive heat and humidity

INACTIVE INGREDIENT

Inactive Ingredients: corn starch, hypromellose, polyethylene glycol, povidone, pregelantized starch, sodium starch glycolate, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETAFEN EXTRA 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0149
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	AZ012
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0149-3	20 in 1 BOX, UNIT-DOSE	01/05/1990
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0149-4	50 in 1 BOX, UNIT-DOSE	01/05/1990
2		2 in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 50332-0149-7	125 in 1 BOX, UNIT-DOSE	01/05/1990
3		2 in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 50332-0149-8	250 in 1 BOX, UNIT-DOSE	01/05/1990
4		2 in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 50332-0149-1	400 in 1 BOX, UNIT-DOSE	01/05/1990
5		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 Drug	M	01/05/1990

Labeler - HART Health (069560969)