NDC | 76168-021-13 |
Set ID | 8600db56-a877-4557-ab71-d46b72d642c9 |
Category | HUMAN OTC DRUG LABEL |
Packager | Velocity Pharma |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active Ingredient
- Purpose
- Uses
-
Warnings
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
- Diabetes
- High blood pressure
- Glaucoma
- 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.
- Direction
- Other Information
- INACTIVE INGREDIENT
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PAIN RELIEVER FEVER REDUCER
acetaminophen,dextromethorphan hydrobromide,phenylephrine hydrochloride,chlorpheniramine maleate tablet, effervescentProduct 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)