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Safetussin Non Drowsy Tablet
FDA Label NDC 55505-231
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 55505-231). 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 one caplet) | Purpose |
|---|---|
Dextromethorphan HBr 10 mg | Cough suppressant |
Guaifenesin 200 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
- 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.
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
- adults and children 12 years and over: take 1-2 caplets every 4 hours as needed.
- Children under 12 years:do not use
Do not take more than 12 caplets in any 24-hour period.
Other Information
- Store at 15° - 30°C (59° - 86°F)
- Keep this carton for future reference on full labeling
Inactive Ingredients
Crospovidone, flavor, Hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, stearic acid, sucralose,
Questions Or Comments?
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Principal Display Panel - 236 Ml Bottle Label
SAFE FOR ADULTS WITH HIGH BLOOD PRESSURE & DIABETES
NDC 55505-231-24
Safetussin® DM
NON-DROWSY
Cough+Chest
Congestion
Dextromethorphan HBr / Cough Suppressant
Guaifenesin / Expectorant
Safe for adults with
High Blood Pressure
Diabetes
- Control cough
- Loosens mucus
- Relives chest congestion
- No decongestants
- No acetaminophen
- No Sugar
- No Alcohol
- No sorbitol
- No fructose
- No gluten
- No dyes
SUGAR & DECONGESTANT FREE
24 Caplets
* Please review the disclaimer below.
