NDC | 55505-173-33 |
Set ID | 0f7e2c22-0c59-4027-ad61-6bdd048a605c |
Category | HUMAN OTC DRUG LABEL |
Packager | Kramer Laboratories |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- Uses
-
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
- ASK DOCTOR/PHARMACIST
- When using this product
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information:
- INACTIVE INGREDIENT
-
PRINCIPAL DISPLAY PANEL
Safetussin® PM
NIGHT TIME
COUGH RELIEF
Cough Suppressant / Antihistamine
Specially formulated for adults with
High Blood Pressure
Diabetes
Controls Cough
Relieves Sneezing
& Runny Nose
No Sugar
No Dyes
No Gluten
No Alcohol
4.0 FL OZ (118mL)
Safetussin® PM
ALIVIA LA TOS
DURANTE LA NOCHE
Antiusivo / Antihistaminíco
SEGURO para los que padecen de
Presión alta
Diabetes
Calma la tos,
alivia estornudos
y goteo de la nariz
Sin Azúcar
Sin Colorantes
Sin Gluten
Sin Alcohol
4 FL. OZ (118 mL)
Safetussin® PM
NIGHT TIME
COUGH RELIEF
Cough Suppressant / Antihistamine
Up To
8 HOURS OF COUGH RELIEF
To Help You Rest
Pharmacist Recommended
Developed by a pharmacist who recognized the need for simple, safe cough relief for adults afflicted with high blood pressure, diabetes or the common cold.
Specially-formulated Safetussin® is free of alcohol, sugar, dyes, decongestants and other ingredients that are unnecessary for safe, adult-strength cough treatment. Pure and simple.
Questions? Comments?
Call 1-800-824-4894 ● safetussin.com
© 2019 Kramer Laboratories, Inc.
Bridgewater, NJ 08807 ● kramerlabs.com
k0519Safetussin® PM
NIGHT TIME
COUGH RELIEF
Cough Suppressant / Antihistamine
Specially formulated for adults with
High Blood Pressure
Diabetes
Controls Cough
Relieves Sneezing & Runny Nose
4 FL. OZ. (118 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL ON BOTTLE IS BROKEN OR MISSING.
K0519
www.kramerlabs.com ● www.safetussin.com
© 2019 Kramer Laboratories, Inc. Bridgewater, NJ 08807 -
INGREDIENTS AND APPEARANCE
SAFETUSSIN PM
dextromethorphan doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55505-173 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextromethorphan (UNII: 7355X3ROTS) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide 7.5 mg in 5 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 3.125 mg in 5 mL Inactive Ingredients Ingredient Name Strength Aspartame (UNII: Z0H242BBR1) benzoic acid (UNII: 8SKN0B0MIM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) glycerin (UNII: PDC6A3C0OX) menthol (UNII: L7T10EIP3A) methylparaben (UNII: A2I8C7HI9T) MINT (UNII: FV98Z8GITP) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) water (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55505-173-33 1 in 1 CARTON 02/09/2017 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/09/2017 Labeler - Kramer Laboratories (122720675) Establishment Name Address ID/FEI Business Operations Denison Pharmecuticals 001207208 manufacture(55505-173)