ALTIPRES PEDIATRIC- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid 
Alternative Pharmacal Corporation

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.

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Drug Facts

Active Ingredients (in each 5 mL tsp.)              Purpose

Dextromethorphan HBr ............... 5 mg ................ Cough Suppressant

Guaifenesin .............................. 75 mg ................ Expectorant

Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Ask a doctor before use if your child has

When using this product, do not exceed recommended dosage

Stop use and ask doctor if

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.

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Indications

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 ingredients citric acid, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose

Questions or comments? 1-305-403-3788

altiprespediatric

ALTIPRES  PEDIATRIC
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN75 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorORANGE (Orange Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53163-103-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2013
Labeler - Alternative Pharmacal Corporation (078528214)

Revised: 12/2020
Document Id: afe0e032-1d25-467b-a9a2-6653d9c815f1
Set id: 42ca9bed-16f0-4f1b-abda-4a7bd0cbb227
Version: 3
Effective Time: 20201223
 
Alternative Pharmacal Corporation