NDC | 14505-399-06 |
Set ID | 8816ec3c-2a26-4bd5-9ba6-8f7fce999470 |
Category | HUMAN OTC DRUG LABEL |
Packager | Pharmalab Enterprises Inc |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
Warnings: Do not exceed recommended dosage.
Do not give to children under 12 years of age.
Liver Toxicity may occur if:- Recommended dosage is exceeded
- Used with other products containing acetaminophen
- Used with moderate amounts of alcohol
Sore Throat Warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly. -
DO NOT USE
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 two 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 DOCTOR
Stop Use and ask a doctor if you have:
- Glaucoma
- Trouble urinating due to enlarged prostate gland
- Cough that occurs with too much phlegm(mucus)
- Persistent or chronic cough as occurs with smoking, asthma or emphysema
- Ask a doctor before use if you are taking sedatives or tranquilizers
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
-
DOSAGE & ADMINISTRATION
Directions: Take only as recommended. See Overdose Warning.
- use dose cup or tablespoon(TBSP). Do not use more than 4 doses in 24 hours
Adults and children 12 years and older: Take 2 TBSP(30ml) every 6 hours, while symptoms persist or as directed by a doctor
Children under 12 years of age: Consult a doctor. Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose(overdose) of acetaminophen and cause serious problems.
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SANATOS NIGHT
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14505-399 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 15 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) ALCOHOL (UNII: 3K9958V90M) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color green Score Shape Size Flavor ANISE (ANISE) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14505-399-06 177 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/04/2010 Labeler - Pharmalab Enterprises Inc (174401088) Registrant - Pharmalab Enterprises Inc (174401088) Establishment Name Address ID/FEI Business Operations Pharmalab Enterprises Inc 174401088 manufacture