Label: PAIN RELIEVER FEVER REDUCER- acetaminophen,dextromethorphan hydrobromide,phenylephrine hydrochloride,chlorpheniramine maleate tablet, effervescent
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 24, 2014
If you are a consumer or patient please visit this version.
- Active Ingredient
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets in 24 hours which is maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat waring: If sore throat is sever, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting consult a doctor promptly. Do not use to sedate children.
do not use:
- with any other drug containing acetaminophen (prescription or not prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug, If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- Heart disease
- Thyroid disease
- High blood pressure
- Cough with excessive phlegm (mucus)
- A breathing problem such as emphysema or chronic bronchitis
- Difficulty in urinating due to enlargement of prostate gland
- Persistent or chronic cough such as occurs with smoking, asthma or emphysema
- A sodium restricted diet
ask your doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin.
- taking sedative or tranquilizers
when using this product
- do not exceed recommended dosage
- may cause marked drowsiness
- avoid alcoholic drinks
- alcohol, sedative and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur especially in children
Stop use and ask a doctor if
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.
- Nervousness, dizziness, or sleeplessness occurs
- If pregnant or breast-feeding, ask a health professional before use
- Keep out of reach of children.
- Other Information
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
PAIN RELIEVER FEVER REDUCER
acetaminophen,dextromethorphan hydrobromide,phenylephrine hydrochloride,chlorpheniramine maleate tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-021 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PONCEAU 4R (UNII: Z525CBK9PG) ISOPROPYL ALCOHOL (UNII: ND2M416302) MANNITOL (UNII: 3OWL53L36A) ORANGE (UNII: 5EVU04N5QU) POVIDONE K30 (UNII: U725QWY32X) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Product Characteristics Color PINK Score no score Shape ROUND Size 25mm Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76168-021-13 6 in 1 BLISTER PACK 1 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/15/2014 Labeler - Velocity Pharma (962198409) Registrant - Velocity Pharma (962198409)