Label: DEXTROMETHORPHAN HBR AND GUAIFENESIN solution
50383-062-10, view more50383-062-11, 50383-062-12
- Packager: Hi-Tech Pharmacal Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated October 5, 2020
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- Active ingredient
- Inactive ingredients
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).
- take every 4 hours
- do not exceed 6 doses in 24 hours
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.
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INGREDIENTS AND APPEARANCE
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 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, UNSPECIFIED FORM (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 03/07/2012 1 NDC:50383-062-05 10 in 1 TRAY 1 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 2 NDC:50383-062-07 10 in 1 CASE 03/07/2012 2 10 in 1 TRAY 2 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 3 NDC:50383-062-11 4 in 1 CASE 03/07/2012 3 NDC:50383-062-10 10 in 1 TRAY 3 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 4 NDC:50383-062-12 10 in 1 CASE 03/07/2012 4 10 in 1 TRAY 4 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product 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. (117696873) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Hi-Tech Pharmacal Co., Inc. 117696873 MANUFACTURE(50383-062) , ANALYSIS(50383-062) , PACK(50383-062)