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©2023 Kramer Laboratories, Inc Bridgewater, NJ 08807
Safetussin Non Drowsy Liquid
FDA Label NDC 55505-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Laboratories for the product Safetussin Non Drowsy (NDC 55505-220). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 30 mL dose cup) | Purpose |
|---|---|
Dextromethorphan HBr 10 mg | Cough suppressant |
Guaifenesin 100 mg | Expectorant |
Uses
▪ temporarily relieves cough due to minor throat and bronchial irritation▪ loosen phlegm (mucus)▪ helps rid bronchial passages of phlegm(mucus)
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
▪ 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
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
▪ do not take more than 6 doses in any 24-hours period▪ This adult product is not intended for use in children under 12 years of age
age | dose |
Adults and children 12 years and over | 10 mL every hours |
Children under 12 years | do not use |
Other Information
- Protect from excessive heat and freezing. Store at 15° - 30°C (59° - 86°F)
Save this package for complete information
Inactive Ingredients
citric acid, glycerin, menthol, natural peppermint flavor, propylene glycol, purified water, sodium benzoate, sucralose,
Questions? Comments?
Call 1-800-824-4894
Principal Display Panel - 236 Ml Bottle Label
SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES
Safetussin® DM
NON-DROWSY
Cough+Chest
Congestion
Dextromethorphan HBr 10 mg / Cough Suppressant
Guaifenesin 100 mg/ Expectorant
Safe for adults with
High Blood Pressure
Diabetes
✓ Control cough✓ Loosens mucus✓ Relives chest congestion
Safetussin® DM contains:
No decongestants
No acetaminophen
No Sugar
No Alcohol
No sorbitol
No fructose
No gluten
No dyes
Pharmacist Recommended Brand
Always read and follow label directions. Do not use longer than 7 consecutive days unless directed by a doctor. Ask a doctor if you have individual health questions.
8 FL OZ (237 mL)
Questions? Comments? Call 1-800-824-4894
©2023 Kramer Laboratories, Inc. Bridgewater, NJ 08807
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