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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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.
Uses
- temporarily relieves cough
- helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus
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.
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
- take every 4 hours
- do not exceed 6 doses in 24 hours
| 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
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 |
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| Labeler - Hi-Tech Pharmacal Co., Inc. (101196749) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Hi-Tech Pharmacal Co., Inc. | 101196749 | MANUFACTURE(50383-062) | |