GUAIFENESIN AND DEXTROMETHORPHAN HBr by Safecor Health, LLC
GUAIFENESIN AND DEXTROMETHORPHAN HBr by
Drug Labeling and Warnings
GUAIFENESIN AND DEXTROMETHORPHAN HBr by is a Otc medication manufactured, distributed, or labeled by Safecor Health, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
GUAIFENESIN AND DEXTROMETHORPHAN HBR- guaifenesin and dextromethorphan hydrobromide liquid
Safecor Health, LLC
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 Ingredients (in each 5 mL = 1 teaspoonful)
Guaifenesin, USP 100 mg
Dextromethorphan HBr, USP 10 mg
Uses:
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
helps loosen phlegm (mucus) and 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.
Do not use if you have ever had an allergic reaction to any of the ingredients in this product.
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic 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 is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Keep this and all drugs out of reach of children. In case of overdose get medical help or contact a Poison Control Center (1-800-222-1222) right away. In case of eye contact, flush with water.
Directions: Follow dosage below or use as directed by a doctor.
Do not take more than 6 doses in any 24-hour period.
| Age | Dose |
| Adults and children 12 years and over | 10 mL (2 teaspoonfuls) every 4 hours |
| Children 6 years to under 12 years | 5 mL (1 teaspoonful) every 4 hours |
| Children 2 years to under 6 years | 2.5 mL (1/2 teaspoonful) every 4 hours |
| Children under 2 years | ask a doctor |
Other Information:
Each teaspoonful (5 mL) contains: sodium 2 mg. Store at room temperature 20°C-25°C (68°F - 77°F); excursions between 15°C-30°C (59°F
- 86°F) are allowed. Protect from freezing. Do not Refrigerate. Protect from light. For more info call 1-800-447-1006
Inactive Ingredients: Cherry Flavor, Citric Acid, FD&C Red # 40, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose, sucrose.
NDC: 48433-221-05 GUAIFENESIN AND DEXTROMETHORPHAN HBr (100 mg / 10 mg per 5 mL) Unit Dose Cup
Mfd. in the U.S.A.
Distributed by: Safecor Health, LLC
4060 Business Park Drive, Columbus, OH 43204
Guaifenesin and Dextromethorphan HBr Oral Solution (100 mg / 10 mg per 5 mL) Unit Dose Cup
Rev: 03/2021 PN5713
3 48433 22105 1
Delivers 5 mL
NDC: 48433-221-05
Guaifenesin and
Dextromethorphan HBr
Oral Solution
100 mg/ 10 mg per 5 mL
Cherry Menthol Flavor
Alcohol Free
348433221051
Pkg By: Safecor Health, LLC
Columbus, OH 43204
| GUAIFENESIN AND DEXTROMETHORPHAN HBR
guaifenesin and dextromethorphan hydrobromide liquid |
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| Labeler - Safecor Health, LLC (828269675) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Safecor Health, LLC | 828269675 | repack(48433-221) | |
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