Label: ALTIPRES PEDIATRIC- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
- NDC Code(s): 53163-103-16
- Packager: Alternative Pharmacal Corporation
- Category: HUMAN OTC DRUG LABEL
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
-
WARNINGS
Warnings
Ask a doctor before use if your child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to the enlargement of the prostate gland
- a cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic as occurs with smoking, asthma, chronic bronchitis or emphysema
When using this product, do not exceed recommended dosage
Stop use and ask doctor if- your child gets nervous, dizzy or sleepless
- 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
-
DO NOT USE
Do not use in a child who is 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 child's prescription drug contains an MAOI; ask a doctor or pharmacist before taking this product -Do not use- in a child under 2 years of age.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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 4 teaspoonfuls (20 mL) every 4 hours
children 6 to under 12 years of age
take 2 teaspoonful (10 mL) every 4 hours
children 2 years to under 6 years of age
take 1 teaspoonful (5 mL) every 4 hours
children under 2 years of age
ask a doctor
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALTIPRES PEDIATRIC
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53163-103 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 75 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) Product Characteristics Color Score Shape Size Flavor ORANGE (Orange Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53163-103-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2013 Labeler - Alternative Pharmacal Corporation (078528214)
