SPL v1
SPL
SPL Set ID d2a9738a-07a0-4882-9291-cc43e6a8ae1a
Route
ORAL
Published
Effective Date 2013-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-09-01

Description

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  


Medication Information

Purpose

Pain reliever/fever reducer   

Cough suppressant   

Antihistamine  

Description

Drug Facts Active ingredients (in each tablespoonful, 15 mL) Acetaminophen 325 mg    Dextromethorphan HBr 15 mg    Doxylamine Succinate 6.25 mg

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.

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



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
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

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.

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
Active Ingredients

Drug Facts



Active ingredients (in each tablespoonful, 15 mL)




Acetaminophen 325 mg   

Dextromethorphan HBr 15 mg   

Doxylamine Succinate 6.25 mg

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

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.

Keep Out of Reach of Children

Keep out of reach of children.

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




Structured Label Content

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



Purpose

Pain reliever/fever reducer   

Cough suppressant   

Antihistamine  

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.

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



Do Not Use (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
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

Overdose Warning (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.

Other Information (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
Active Ingredients (Active ingredients)

Drug Facts



Active ingredients (in each tablespoonful, 15 mL)




Acetaminophen 325 mg   

Dextromethorphan HBr 15 mg   

Doxylamine Succinate 6.25 mg

Inactive Ingredients (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

When Using This Product (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 (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 (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use)
  • if you are taking the blood thinning drug warfarin
  • if you are taking sedatives or tranquilizers




Advanced Ingredient Data


Raw Label Data

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