WALGREENS NIGHTTIME KIDS HONEY COLD COUGH CONGESTION- doxylamine succinate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid

Walgreens Nighttime Kids by

Drug Labeling and Warnings

Walgreens Nighttime Kids by is a Otc medication manufactured, distributed, or labeled by WALGREENS CO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients (in each 15 mL)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Cough suppressant

Antihistamine

Nasal decongestant

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

Warnings

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

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

Ask a doctor or pharmacist before use 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

• ▪ 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.

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

Keep out of reach of children.

Overdose warning

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

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

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

Questions?

1-866-467-2748

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Distributed by:

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.

INGREDIENTS AND APPEARANCE

WALGREENS NIGHTTIME KIDS  HONEY COLD COUGH CONGESTION
doxylamine succinate, phenylephrine hydrochloride and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-6248
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	HONEY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-6248-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/01/2023

Labeler - WALGREENS CO (008965063)