NDC | 70005-046-01 |
Set ID | 9ad5cc14-01f6-4315-bebf-267ef1c952eb |
Category | HUMAN OTC DRUG LABEL |
Packager | We Care Distributor Inc. |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredient (in each 15 mL tablespoon)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses. Severe liver damage may occur if adult/child takes:
- more than 4,000 mg of acetaminophen in 24 hours
- 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 two 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
- to make a child sleepy
Ask a doctor before use if you have
- liver disease
- glaucoma
- a sodium-restricted diet
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or occurs with smoking, asthma chronic bronchitis or emphysema
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- 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
Stop use and ask a doctor if
- redness or swelling is present
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than recommended dose may cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- take only as directed. (see overdose warning)
- use dose cup
- do not exceed 4 doses per 24 hours
adults and children 12 years and over 30 mL every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use - when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
See New Warnings Information
Compare to NyQuil® Cold & Flu Active Ingredients
NiteTime
Cold & Flu
Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine
Multi-Symptom Relief
Aches, Fever - Acetaminophen
Cough - Dextromethorphan HBr
Sneezing, Runny Nose - Doxylamine Succinate
Original Flavor
10% Alcohol
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INGREDIENTS AND APPEARANCE
NITE TIME COLD FLU RELIEF
acetaminophen,dextromethorphan hbr, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-046 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) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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 GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color GREEN (Bright) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70005-046-01 1 in 1 CARTON 08/10/2016 1 120 mL in 1 BOTTLE; 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 08/10/2016 Labeler - We Care Distributor Inc. (079832998) Establishment Name Address ID/FEI Business Operations PURINE PHARMA LLC 019950491 manufacture(70005-046)