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Night Time MULTI-SYMPTOM COLD/FLU RELIEF

Medically reviewed on April 2, 2018

Dosage form: liquid
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-135

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.

Active ingredients

Drug Facts

Active ingredients (in each tablespoonful, 15 mL)


Acetaminophen 325 mg   
Dextromethorphan HBr 15 mg   
Doxylamine Succinate 6.25 mg

Purpose

Pain reliever/fever reducer   
Cough suppressant   
Antihistamine  

Keep out of reach of children

Keep out of reach of children.

Uses

temporarily relieves cold/flu symptoms:

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


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
  • 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 sleepy

Ask a doctor before use if you have
  • liver disease
  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a sodium restricted diet

Ask a doctor or pharmacist before use
  • if you are taking the blood thinning drug warfarin
  • if you are taking sedatives or tranquilizers


When using this product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery


Stop use and ask a doctor if
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

  • These could be signs of a serious condition.

If pregnant or breast-feeding

ask a health professional before use.

Overdose warning

 Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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 recommended (see Overdose warning)
  • use dose cup or tablespoon (TBSP)
  • do not take more than 4 doses in any 24-hours


Other information
  • each tablespoonful (15 mL) contains: sodium 23 mg
  • dosage cup provided
  • store between 20-25° C (68-77° F)
  • do not refrigerate
  • Keep carton for full directions for use

Inactive ingredients

anhydrous citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

NDC 68016-135-00
COMPARE TO THE ACTIVE INGREDIENTS IN DELSYM® NIGHT TIME MULTI-SYMPTOM

Premier Value®

Night Time
MULTI-SYMPTOM COLD/FLU RELIEF

Acetaminophen……Pain Reliever/Fever Reducer
Dextromethorphan HBr……Cough Suppressant
Doxylamine Succinate ……………Antihistamine

Cough
Fever and Body Aches
Sore Throat
Sneezing and Runny Nose
Cherry Flavored Liquid

For Ages 12 +

4 FL OZ (120 mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by Reckitt Benckiser Inc.,Distributor of Delsym® Night Time Multi-Symptom

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

DISTRIBUTED BY
CHAN DRUG CONSORTIUM
3301 NW BOCO RATON BLVD
SUITE 101, BOCA RATON FL 33431
BX-007

NIGHT TIME  MULTI-SYMPTOM COLD/FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-135
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
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SODIUM CITRATE 
SUCROSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (Cherry Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-135-00120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/01/2012
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIOperations
AptaPharma Inc.790523323manufacture(68016-135)

 
Chain Drug Consortium, LLC

← See all Night Time MULTI-SYMPTOM COLD/FLU RELIEF brands

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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