SPL v1
SPL
SPL Set ID f6b3f636-2bc4-4f0c-9326-bc350b3ae3c3
Route
ORAL
Published
Effective Date 2013-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (6.25 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Maltitol Propylene Glycol Water Sodium Benzoate Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-09-01

Description

Drug Facts Active ingredients (in each 5 mL tsp) Diphenhydramine HCL,USP 6.25 mg Phenylephrine HCL, USP 2.5 mg

Purpose

Antihistamine / Cough Suppressant Nasal Decongestant


Medication Information

Purpose

Antihistamine / Cough Suppressant

Nasal Decongestant

Description

Drug Facts Active ingredients (in each 5 mL tsp) Diphenhydramine HCL,USP 6.25 mg Phenylephrine HCL, USP 2.5 mg

Uses
  • temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold
  • temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy nose or throat                  
Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on the skin
  • to make a child sleepy
  • 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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.

Directions
  • do not use more than directed
  • do not take more than 6 doses in any 24-hour period
  • use dosage cup or teaspoon
Questions?

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



 1-877-798-5944

Product Label

NDC 68016-143-00



*COMPARE TO THE ACTIVE INGREDIENTS IN DELSYM® CHILDREN'S NIGHT TIME COUGH and COLD



Premier Value®

Children's Night Time

COUGH and COLD RELIEF



Diphenhydramine HCL..........Antihistamine / Cough Suppressant

Phenylephrine HCL ............ Nasal Decongestant



Sneezing

Runny Nose

Cough

Stuffy Nose



Grape Flavored Liquid

4 FL OZ (118mL)



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® Children's Night Time Cough and Cold

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

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

BX-008

Other Information
  • each teaspoonful contains: sodium 3 mg
  • store between 20-25 ° C (68-77° F)
  • do not refrigerate
  • dosage cup provided
  • Keep carton for full directions for use
Active Ingredients

Drug Facts



Active ingredients


(in each 5 mL tsp)



Diphenhydramine HCL,USP 6.25 mg

Phenylephrine HCL, USP 2.5 mg

Inactive Ingredients

acesulfame potassium, citric acid anhydrous, edeate disodium, FD and C blue #1, FD and C red # 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

When Using This Product
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occus
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.



These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children.



 In case of overdose, get medical help or contact a Poison Control center right away.

Ask A Doctor Before Use If the Child Has
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If the Child Is
  • taking sedatives or tranquilizers.


Structured Label Content

Uses
  • temporarily controls cough due to minor throat and bronchial irritation and relieves nasal congestion as may occur with a cold
  • temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • runny nose
  • itchy, watery eyes
  • itchy nose or throat                  
Purpose

Antihistamine / Cough Suppressant

Nasal Decongestant

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on the skin
  • to make a child sleepy
  • 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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.

Directions
  • do not use more than directed
  • do not take more than 6 doses in any 24-hour period
  • use dosage cup or teaspoon
Questions?

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



 1-877-798-5944

Product Label

NDC 68016-143-00



*COMPARE TO THE ACTIVE INGREDIENTS IN DELSYM® CHILDREN'S NIGHT TIME COUGH and COLD



Premier Value®

Children's Night Time

COUGH and COLD RELIEF



Diphenhydramine HCL..........Antihistamine / Cough Suppressant

Phenylephrine HCL ............ Nasal Decongestant



Sneezing

Runny Nose

Cough

Stuffy Nose



Grape Flavored Liquid

4 FL OZ (118mL)



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® Children's Night Time Cough and Cold

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

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

BX-008

Other Information (Other information)
  • each teaspoonful contains: sodium 3 mg
  • store between 20-25 ° C (68-77° F)
  • do not refrigerate
  • dosage cup provided
  • Keep carton for full directions for use
Active Ingredients (Active ingredients)

Drug Facts



Active ingredients


(in each 5 mL tsp)



Diphenhydramine HCL,USP 6.25 mg

Phenylephrine HCL, USP 2.5 mg

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, citric acid anhydrous, edeate disodium, FD and C blue #1, FD and C red # 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

When Using This Product (When using this product)
  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occus
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.



These could be signs of a serious condition.

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

Keep out of reach of children.



 In case of overdose, get medical help or contact a Poison Control center right away.

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • persistent or chronic cough such as occurs with asthma
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If the Child Is (Ask a doctor or pharmacist before use if the child is)
  • taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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