DEXTROMETHORPHAN HBR AND GUAIFENESIN- dextromethorphan hydrobromide and guaifenesin solution 
Hi-Tech Pharmacal Co., Inc.

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 ingredient

Each 5 mL (1 teaspoonful) contains:

Dextromethorphan HBr ................................10 mg

Guaifenesin ................................................100 mg

Inactive ingredients

Acesulfame potassium, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Purpose

Cough Suppressant

Expectorant

Uses

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

Stop use and ask a doctor if

  • a cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache 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.

Professional note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5- hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Directions

Age Dose
Adults & children 12 years & over 10 mL (2 teaspoonfuls)
Children 6 years to under 12 years 5 mL (1 teaspoonful)
Children 2 years to under 6 years 2.5 mL (1/2 teaspoonful)
Children under 2 years Ask a doctor

How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

Storage: Keep tightly closed. Store at controlled room temperature 20-25° C (68-77°F). [See USP] Protect from light.

QUESTIONS OR COMMENTS?

Call 1-800-262-9010.


Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701


Rev.062:00 10/10

MG #29851

Package/Label Principal Display Panel

Lid_062_10 mL

Delivers 10 mL

NDC 50383-062-10

DEXTROMETHORPHAN HBr & GUAIFENESIN ORAL SOLUTION

20 mg/200 mg per 10 mL

Sugar Free/Alcohol Free

COUGH SUPPRESSANT/EXPECTORANT

SEE INSERT

FOR INSTITUTIONAL USE ONLY

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 062:00 10/10

DEXTROMETHORPHAN HBR AND GUAIFENESIN 
dextromethorphan hbr and guaifenesin solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50383-062
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ASPARTAME (UNII: Z0H242BBR1)  
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
MENTHOL (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50383-062-06 4 in 1 CASE
1 NDC:50383-062-05 10 in 1 TRAY
1 5 mL in 1 CUP, UNIT-DOSE
2 NDC:50383-062-07 10 in 1 CASE
2 10 in 1 TRAY
2 5 mL in 1 CUP, UNIT-DOSE
3 NDC:50383-062-11 4 in 1 CASE
3 NDC:50383-062-10 10 in 1 TRAY
3 10 mL in 1 CUP, UNIT-DOSE
4 NDC:50383-062-12 10 in 1 CASE
4 10 in 1 TRAY
4 10 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 03/07/2012
Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
Establishment
Name Address ID/FEI Business Operations
Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(50383-062)

Revised: 3/2013
Document Id: eda4db26-e020-4ca8-a63f-590484a06824
Set id: ed74de02-852a-4dfe-8462-fa22044a2258
Version: 2
Effective Time: 20130325
 
Hi-Tech Pharmacal Co., Inc.