GUAIASORB DM- dextromethorphan hydrobromide and guaifenesin liquid 
Geri-Care Pharmaceuticals, Corp

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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GUAIASORB DM

Active Ingredients (in each 5 mL teaspoonful)

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Purpose

Expectorant
Cough Suppressant

Uses

  • temporarily relieves cough due to minor throat and bronchial irritation
  • helps loosen phlegm (mucus)
  • helps thin bronchial secretions to make coughs more productive

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.

Ask a doctor before use if you have

  • a cough with too much phlegm (mucus) that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or accompanied by fever, rash, or headaches that lasts. These could be signs of a serious condition

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.

Directions

  • take every 4 hours as needed, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • do not exceed recommended dose

Adult and children 12 years and over2 teaspoonfuls (10 mL)
Children under 12 yearsDo not use

Inactive ingredients

citric acid, flavor, glycerin, menthol, sodium saccharin, sodium benzoate, sorbitol, water

Other information

  • store at room temperature between 15°-30°C (59° -86°F)
  • TAMPER EVIDENT: Do not use this product if breakaway band on cap is broken or missing

Distributed by:

GERI-CARE PHARMACEUTICALS CORP.
1650 63rd Street
Brooklyn, NY 11204 USA

755

GUAIASORB DM 
dextromethorphan hydrobromide and guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-756
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57896-756-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/201509/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/05/199509/30/2020
Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
Registrant - Geri-Care Pharmaceuticals, Corp (611196254)

Revised: 12/2019
Document Id: 9a0032c4-afc5-4eba-e053-2995a90ad301
Set id: a48f0062-7e70-40a8-814b-cb162664ea77
Version: 8
Effective Time: 20191218
 
Geri-Care Pharmaceuticals, Corp