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nite time cold flu relief

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: We Care Distributor Inc.
NDC Code: 70005-046

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

 NiteTime Cold and Flu Drug Facts

Active ingredient (in each 15 mL tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

  • minor aches and pains
  • headache
  • sore throat
  • runny nose and sneezing
  • fever
  • cough due to minor throat and bronchial irritation

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.

If pregnant or breast-feeding,

ask a health professional before use.

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.

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 over30 mL every 6 hours
children 4 to under 12 yearsask a doctor
children under 4 yearsdo not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information
  • each 15 mL (tablespoon) contains: sodium 46 mg
  • store at 15°-30°C (59°-86°F)
  • protect from freezing

Inactive ingredients

alcohol, citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate, sodium benzoate

Questions or comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

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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

NITE TIME  COLD FLU RELIEF
acetaminophen,dextromethorphan hbr, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-046
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
FD&C YELLOW NO. 6 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
SODIUM BENZOATE 
Product Characteristics
ColorGREEN (Bright) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70005-046-011 BOTTLE in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/10/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIOperations
PURINE PHARMA LLC019950491manufacture(70005-046)

Revised: 08/2016
 
We Care Distributor Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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