FDA Label for Safetussin DM
View Indications, Usage & Precautions
Safetussin DM Product Label
The following document was submitted to the FDA by the labeler of this product Kramer Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
| Active ingredients (in each 5ml tsp) | Purpose |
| Dextromethorphan HBr,USP 10 mg | Cough Suppressant |
| Guaifenesin, USP 100 mg | Expectorant |
Uses
- temporarily relieves cough due to minor throat and bronchial irritation
- loosens phlegm (mucus)
- helps rid bronchial passages of phlegm (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 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
Otc - Stop Use
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.
Nursing Mothers
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-hour 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 | 2 teaspoons every 4 hours |
| children under 12 years | do not use |
Other Information:
- Protect from excessive heat and freezing. Store at 15° - 30° C (59° - 86° F)
- Phenylketonurics: each teaspoon contains phenylalanine 4.2 mg
Save this package for complete information
Inactive Ingredient
Inactive ingredients: aspartame, benzoic acid, citric acid, glycerin, menthol, methylparaben, natural peppermint flavor, propylene glycol, propylparaben, purified water
Principal Display Panel
Safetussin DM
DAY TIME COUGH RELIEF
COUGH SUPPRESSANT/ EXPECTORANT
Relieves Cough
Loosens Mucus
SAFE For Those With:
High Blood Pressure
Diabetes
SUGAR FREE
■ Dye Free
■ Gluten Free
■ Alcohol Free
4 FL. OZ (120 ml.)
Safetussin DM
ALIVIA LA TOS DURANTE EL DIA
ANTITUSIVO / EXPECTORANTE
Alivia la tos
Descongestiona el Pecho
SEGURO para los que padecen de:
Presión alta
Diabetes
SIN AZÚCAR
■ Sin Colorantes
■ Sin Gluten
■ Sin Alcohol
4 FL. OZ (120 ml.)
NON-DROWSY
Safe Cough Relief
Pure and Simple
Safetussin® is specially formulated, free of alcohol, sugar, dyes, decongestants and other unwanted ingredients that are not needed for safe, adult strength cough treatment.
The Clear Choice!
Pharmacist Recommended
Dosage Cup Included
Vaso Dosificador Incluido
Certified
WBENC
Women's Business Enterprise
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL ON CAP IS BROKEN, TORN OR MISSING
KRAMER LABORATORIES
Coral Gables, FL 33134 ● 1-800-824-4894
www.kramerlabs.com ● www.safetussin.com
K0617
Safetussin® DM
DAY TIME COUGH RELIEF
COUGH SUPPRESSANT/ EXPECTORANT
SAFE For Those With:
High Blood Pressure
Diabetes
4 FL. OZ. (120 mL)
KRAMER Laborites
Coral Gables, FL 33134
www.kramerlabs.com
www.safetussin.com
K0617
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