Label: CETAFEN COUGH AND COLD- cold medicine tablet
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated June 5, 2020
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
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 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 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
- KEEP OUT OF REACH OF CHILDREN
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
- INACTIVE INGREDIENT
- 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)