FDA.reportPublic FDA data

Daytime and Nighttime Cough and Chest Congestion Childrens

Manufacturer
CVS Pharmacy
Effective date
2026-08-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-08-21 02:01:01

Label at a glance#

ProductDaytime and Nighttime Cough and Chest Congestion Childrens
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, CHLORPHENIRAMINE MALEATE
Label structure11 sections

Indications and uses

DAYTIME • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes NIGHTTIME • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing...

Dosage and administration

DAYTIME • measure only with dosing cup provided. • keep dosing cup with product • mL= milliliter • do not take more than 6 doses in any 24-hour period age dose Children under 4 years Do not use Children 4 to under 6 years 5 mL every 4 hours Children 6 to under 12 years 10 mL every 4 hours Adults and children 12 years and older 20 mL every 4 hours NIGHTTIME • measure only with dosing cup provided. • keep dosing cup...

Storage and handling

DAYTIME • each 5 mL contains: sodium 3 mg • store at room temperature. Do not refrigerate • contain low sodium • do not use if printed seal under cap is torn or missing NIGHTTIME • each 10 mL contains: sodium 3 mg • store at room temperature. Do not refrigerate • contain low sodium • do not use if printed seal under cap is torn or missing

Label contents#

Full prescribing information#

Active ingredients Day Time (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr USP 5 mg

Guaifenesin. USP 100 mg

Active ingredients for Nighttime (in each 10 mL)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate, USP 2 mg

Dextromethorphan HBr USP 15 mg

Purposes for Day Time

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Purpose for Night Time

OTC - PURPOSE SECTION

Antihistamine

Cough suppressant

Uses

INDICATIONS & USAGE SECTION

DAYTIME

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

NIGHTTIME

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itching of the nose or throat 
  • itchy, watery eyes

Warnings

WARNINGS SECTION

Do not us

OTC - DO NOT USE SECTION

DAYTIME

  • 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.

NIGHTTIME

  • to sedate a child or 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 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

DAYTIME

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

NIGHTTIME

  • trouble urinating due to an enlarges prostate gland
  • glaucoma
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

NIGHTTIME

taking sedatives or tranquilizers.

When using this product

OTC - WHEN USING SECTION

NIGHTTIME

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

DAYTIME

  • cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

NIGHTTIME

  • cough last more than 7 days, comes back or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

DAYTIME

ask a health professional before use.

NIGHTTIME

ask a health professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DAYTIME

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

NIGHTTIME

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

Directions

DOSAGE & ADMINISTRATION SECTION

DAYTIME

  • measure only with dosing cup provided.
  • keep dosing cup with product
  • mL= milliliter
  • do not take more than 6 doses in any 24-hour period

age

dose

Children under 4 years

Do not use

Children 4 to under 6 years

5 mL every 4 hours

Children 6 to under 12 years

10 mL every 4 hours

Adults and children 12 years and older

20 mL every 4 hours


NIGHTTIME

  • measure only with dosing cup provided.
  • keep dosing cup with product
  • mL= milliliter
  • do not take more than 4 doses in any 24-hour period

age

dose

Children under 6 years

Do not use

Children 6 to under 12 years

10 mL every 6 hours

Adults and children 12 years and older

20 mL every 6 hours

Other information

STORAGE AND HANDLING SECTION

DAYTIME

  • each 5 mL contains: sodium 3 mg
  • store at room temperature. Do not refrigerate
  • contain low sodium
  • do not use if printed seal under cap is torn or missing

NIGHTTIME

  • each 10 mL contains: sodium 3 mg
  • store at room temperature. Do not refrigerate
  • contain low sodium
  • do not use if printed seal under cap is torn or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients for Day Time 

anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, natural and artificial flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Inactive ingredients for Night Time 

anhydrous citric acid, FD&C Red # 40, natural and artificial flavors, potassium sorbate, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Children's Robitussin® Cough & Chest Congestion DM*

Non-Drowsy

Children's

Cough & Chest Congestions DM

Each 5 mL dose of oral solution contains:

DEXTROMETHORPHAN HBr, USP 5 mg

Cough suppressant

GUAIFENESIN, USP 100 mg

Expectorant

Relieves

  • Chest congestion/mucus
  • Cough

For Ages 4 and over

Grape Flavor

Naturally and Artificially Flavored

Dosage cup included

TWO 4 FL OZ (118 mL) BOTTLES TOTAL – 8 FL OZ (236 mL)

Compare to the active ingredients in Children's Robitussin® Nighttime Cough DM*

NDC# 69842-657-08

Children's

Nighttime Cough DM

Each 10 mL dose of oral solution contains:

CHLORPHENIRAMINE MALEATE, USP 2 mg

Antihistamine

DEXTROMETHORPHAN HBr, USP 15 mg

Cough suppressant

Relieves

  • Cough up to 8 hours
  • Runny nose

Alcohol free

For Ages 6 & over

Fruit Punch Flavor

Naturally and Artificially Flavored

Dosage cup included

TWO 4 FL OZ (118 mL) BOTTLES TOTAL – 8 FL OZ (236 mL)

*This product is not manufactured or distributed by Pfizer, owner of the registered trademarks Children’s Robitussin® Cough + Chest Congestion DM and Children’s Robitussin® Nighttime Cough DM.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2018 CVS/pharmacy

CVS.com®

1-800-SHOP CVS

V-12431

CVS® Quality

Money Back Guarantee

CVS Health Children's Daytime & Nighttime Cough & Chest Congestion DM
CVS Health Children's Daytime & Nighttime Cough & Chest Congestion DM

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeITF917314image-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-65769842-657-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-08-22full-release2026-06-01 00:17:37

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime and Nighttime Cough and Chest Congestion ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATECVS Pharmacy347f1731-5b85-4220-ae2b-9497a3afa4ed2026-08-19WarningsExact identifier
ndc (package): 69842-657-08
ndc (product): 69842-657
ndc11 (package): 69842065708
spl id: a7615299-bda6-4721-b887-2ee4d4b299ae
spl set id: 347f1731-5b85-4220-ae2b-9497a3afa4ed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.