CETAFEN COUGH AND COLD- cold medicine tablet

CETAFEN COUGH AND COLD by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each tablet):

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

PURPOSE

Purpose:

Pain Reliever/Fever Reducer

Cough Suppressant

Expectorant

Nasal Decongestant

INDICATIONS & USAGE

Uses:

Temporarily relieves these cold/flu symptoms

• cough
• sore throat
• headache
• minor aches and pains
• nasal congestion
• helps loosen phlegm (mucus) and bronchial secretions to make coughs more productive

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
• blisters
• rash

Sore throat warning:

If sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor right away.

DO NOT USE

Do not use

• with any other product containing acetaminophen (prescription or non-prescription)
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric or emotional conditions, or Pakinson's disease), or for 2 weeks after stopping the MAOI drug or if you do not know if your prescription drug contains an MAO.

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

• heart, liver or thyroid desease
• high blood pressure
• diabetes or glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem or a cough with too much phlegm (mucus) or a cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

STOP USE

Stop use and ask a doctor if

• an allergic reaction occurs, seek medical help right away
• new symptoms occur
• you get nervous, dizzy, or sleepless
• pain, nasal congestion or cough gets worse or last for more than 7 days
• redness or swelling is present
• fever gets worse or lasts for more than 3 days
• cough comes back or occurs with rash or headache that lasts

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 wasrning:

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 call 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 tablets every 6 to 8 hours while symptoms persist.
• do not take more than 8 tablets in 24 horus unless directed by a doctor

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients:

Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETAFEN COUGH AND COLD 
cold medicine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0129
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0129-4	50 in 1 BOX, UNIT-DOSE	03/14/2007
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0129-7	125 in 1 BOX, UNIT-DOSE	03/14/2007
2		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	03/14/2007

Labeler - HART Health (069560969)