Label: ALTIPRES-B- brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
- NDC Code(s): 53163-101-16
- Packager: Alternative Pharmacal Corporation
- 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.
Drug Label Information
Updated December 23, 2020
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- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
- temporarily relieves symptoms due to hay fever or other upper respiratory allergies:
- sneezing
- itchy nose or throat
- runny nose
- itchy, water eyes
- nasal congestion
- temporarily controls cough due to minor throat and bronchial irritation associated with inhaled irritants
- temporarily restores freer breathing through nose
-
WARNINGS
Warnings
Do not use 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. Do not use on a child under 2 years of age.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- glaucoma
- diabetes
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- giving this product to children who are taking sedatives or tranquilizers
- if you are taking sedatives or tranquilizers
-
DO NOT USE
Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's doctor.
When using this product
- do not use more than directed
- may cause drowsiness
- avoid alcoholic drink
- alcohol, sedatives and tranquilizers may increase drowsiness effect
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- you get nervous, dizzy or sleeplessness
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
-
DOSAGE & ADMINISTRATION
Directions Do not exceed more than 6 doses in any 24-hour period.
adults and children 12 years of age and over
take 1 teaspoonfuls (5 mL) every 4 hours
children 6 to under 12 years of age
take 1/2 teaspoonfuls (2.5mL) every 4 hours
children 2 years to under 6 years of age
ask a doctor
children under 2 years of age
do not use
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALTIPRES-B
brompheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53163-101 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 4 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE (grape flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53163-101-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/01/2012 Labeler - Alternative Pharmacal Corporation (078528214)
