FDA Label for Safetussin PM
View Indications, Usage & Precautions
Safetussin PM 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 7.5 mg | Cough Suppressant |
| Doxylamine Succinate 3.125 mg | Antihistamine |
Uses
- temporarily relieves cough
- runny nose and sneezing
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. • to make a child sleep.
Ask A Doctor Before Use If You Have
- asthma
- emphysema
- glaucoma
- excessive phlegm (mucus)
- breathing problem
- chronic bronchitis
- persistent or chronic cough
- cough associated with smoking
- trouble urinating due to enlarged prostate gland
- a sodium-restricted diet
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
When Using This Product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
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.
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 4 doses in any 24-hour period
| age | dose |
| adults and children 12 years and over | 4 teaspoons every 6 hours |
| children 4 to 12 years | ask a doctor |
| children under 4 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® PM
NIGHT TIME COUGH RELIEF
COUGH SUPPRESSANT/ ANTIHISTAMINE
Controls Cough
Relieves Sneezing & Runny Nose
SAFE For Those With:
High Blood Pressure
Diabetes
SUGAR FREE
■ Dye Free
■ Gluten Free
■ Alcohol Free
4 FL. OZ (120 mL)
Safetussin® PM
ALIVIA LA TOS DURANTE LA NOCHE
Calma la tos
Alivia estomudos & goteo de la nariz
SEGURO para los que padecen de:
Presión alta
Diabetes
SIN AZÚCAR
■ Sin Colorantes
■ Sin Gluten
■ Sin Alcohol
4 FL. OZ (120 mL)
Up To 8 Hours Of Cough Relief To Help You Rest
Safe Cough Relief
Pure and Simple
Safetussin® was developed by a pharmacist who recognized the special needs of many of his customers afflicted with high blood pressure, diabetes, and those looking for simple, safe cough relief.
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
KRAMER
CONSUMER HEALTHCARE
A division of Kramer Laboratories
Coral Gables, FL 33134
1-800-824-4894
www.kramerlabs.com
www.safetussin.com
k0916
Safetussin® PM
NIGHT TIME COUGH RELIEF
COUGH SUPPRESSANT/ ANTIHISTAMINE
Controls Cough
Relieves Sneezing & Runny Nose
SAFE For Those With:
High Blood Pressure
Diabetes
4 FL. OZ. (120 mL)
KRAMER
CONSUMER HEALTHCARE
A division of Kramer Laboratories
Coral Gables, FL 33134
1-800-824-4894
www.kramerlabs.com
www.safetussin.com
k0916
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