Walgreens Nighttime Kids Cold & Cough + Congestion

Walgreens Nighttime Kids Cold & Cough + Congestion
SPL v4
SPL
SPL Set ID c0f317cd-723d-47f2-b600-aaeae6399482
Route
ORAL
Published
Effective Date 2022-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Edetate Disodium D&c Yellow No. 10 Fd&c Green No. 3 Fd&c Red No. 40 Fd&c Yellow No. 6 Glycerin Propyl Gallate Propylene Glycol Water Sodium Citrate, Unspecified Form Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01

Description

Drug Facts

Purpose

Cough suppressant Antihistamine Nasal decongestant


Medication Information

Purpose

Cough suppressant

Antihistamine

Nasal decongestant

Description

Drug Facts

Uses

temporarily relieves common cold symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take only as directed
  • only use dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15 mL every 4 hrs

children 4 to under 6 yrs

do not use unless directed by a doctor

children under 4 yrs

do not use

Do Not Use
  • 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?

1-866-467-2748

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Other Information
  • each 15 mL contains:sodium 12 mg
  • store at room temperature
Inactive Ingredients

Anhydrous citric acid, carboxymethylcellulose sodium, disodium edetate, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, , xanthan gum

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
  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

Active Ingredients (in Each 15 Ml)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
Principal Display Panel 236 Ml Bottle Label

Compare to the active ingredients in Kids Vicks ®NyQuil™ Honey Cold & Cough + Congestion*

NDC 0363-6248-08

Nighttime

Kid’s

Cold & Cough + Congestion

Doxylamine Succinate, Phenylephrine HCl, Dextromethorphan HBr

  • Sneezing, Runny Nose
  • Nasal Congestion
  • Cough

No Added Alcohol & Acetaminophen Free

Honey Flavor

Naturally and Artificially Flavored

8 FL OZ (236 mL)

*This Product is not manufactured or distributed by Procter & Gamble, the distributor of Kids Vicks ®NyQuil™ Honey Cold & Cough + Congestion.

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Uses

temporarily relieves common cold symptoms:

  • nasal congestion
  • sinus congestion & pressure
  • cough due to minor throat & bronchial irritation
  • cough to help you sleep
  • runny nose & sneezing
  • reduces swelling of nasal passages
  • temporarily restores freer breathing through the nose
  • promotes nasal and/or sinus drainage
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Cough suppressant

Antihistamine

Nasal decongestant

Directions
  • take only as directed
  • only use dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15 mL every 4 hrs

children 4 to under 6 yrs

do not use unless directed by a doctor

children under 4 yrs

do not use

Do Not Use (Do not use)
  • 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?

1-866-467-2748

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Other Information (Other information)
  • each 15 mL contains:sodium 12 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

Anhydrous citric acid, carboxymethylcellulose sodium, disodium edetate, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, , xanthan gum

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)
  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or occur with a fever
  • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache.

These could be signs of a serious condition.

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, or emphysema
Principal Display Panel 236 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label)

Compare to the active ingredients in Kids Vicks ®NyQuil™ Honey Cold & Cough + Congestion*

NDC 0363-6248-08

Nighttime

Kid’s

Cold & Cough + Congestion

Doxylamine Succinate, Phenylephrine HCl, Dextromethorphan HBr

  • Sneezing, Runny Nose
  • Nasal Congestion
  • Cough

No Added Alcohol & Acetaminophen Free

Honey Flavor

Naturally and Artificially Flavored

8 FL OZ (236 mL)

*This Product is not manufactured or distributed by Procter & Gamble, the distributor of Kids Vicks ®NyQuil™ Honey Cold & Cough + Congestion.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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