NDC | 53807-521-06 |
Set ID | afb89586-4533-411b-95f5-3582418c6cf5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Rij Pharmaceutical Corporation |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- Uses
-
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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
- if you are allergic to acetaminophen or any of the ingredients in this product.
Ask a doctor before use if you have
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- A breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
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
-
Directions
- take only as recommended - see Overdose warning
- use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hrs
Adults and children 12 years and over 2 TBSP (30 ml) every 6 hrs Children 4 to 12 years Ask a doctor Children under 4 years Do not use - Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
NITE TIME COLD MEDICINE
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53807-521 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 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 alcohol (UNII: 3K9958V90M) citric acid monohydrate (UNII: 2968PHW8QP) D&C Yellow No. 10 (UNII: 35SW5USQ3G) FD&C Green No. 3 (UNII: 3P3ONR6O1S) FD&C Yellow No. 6 (UNII: H77VEI93A8) high fructose corn syrup (UNII: XY6UN3QB6S) polyethylene glycols (UNII: 3WJQ0SDW1A) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) saccharin sodium (UNII: SB8ZUX40TY) sodium benzoate (UNII: OJ245FE5EU) sodium citrate (UNII: 1Q73Q2JULR) Product Characteristics Color GREEN Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53807-521-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/16/1999 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/16/1999 Labeler - Rij Pharmaceutical Corporation (144679156) Establishment Name Address ID/FEI Business Operations Rij Pharmaceutical Corporation 144679156 manufacture(53807-521)