Label at a glance#

ProductCVS Baby Nighttime Cold and Cough

Active ingredientMATRICARIA RECUTITA, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM IODIDE

Label structure9 sections

Indications and uses

Temporarily relieves the symptoms of runny nose and eyes, cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.

Dosage and administration

Measure only with the dosing syringe provided Do not use dosing syringe with other products On dosing syringe, mL = milliliter, tsp = teaspoon children under 6 months of age consult a licensed health care professional before using this product children 6 months to under 1 year of age 2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours) children 1 to 3 years of age 5 mL or 1 teaspoon up to 6 times daily (every ...

Storage and handling

Do not use if imprinted tamper band is broken or missing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Chamomilla 6X HPUS	occasional sleeplessness
Eupatorium Perfoliatum 6X HPUS	headache, cough, sneezing
Euphrasia Officinalis 6X HPUS	runny eyes and nose
Gelsemium Sempervirens 6X HPUS	sneezing with stuffy nose
Kali Iodatum 6X HPUS	headache, runny eyes and nose

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of runny nose and eyes, cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

for persistent or chronic cough such as occurs with asthma, smoking or emphysema
if cough is accompanied by excessive mucus, unless directed by a licensed health care professional

A persistent cough may be a sign of a serious condition.

Stop use and ask a doctor if

OTC - STOP USE SECTION

symptoms persist for more than 7 days or worsen
symptoms are accompanied by high fever (101°F)
cough tends to recur or is accompanied by high fever, rash or persistent headache

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Measure only with the dosing syringe provided
Do not use dosing syringe with other products
On dosing syringe, mL = milliliter, tsp = teaspoon

children under 6 months of age	consult a licensed health care professional before using this product
children 6 months to under 1 year of age	2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours)
children 1 to 3 years of age	5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

Other information

STORAGE AND HANDLING SECTION

Do not use if imprinted tamper band is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

SPL UNCLASSIFIED SECTION

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

♥CVS
Health _™

Compare to the active
ingredients of Hyland's ^®
Baby Nighttime Tiny
Cold Syrup ^†

NDC 69842-411-01

Homeopathic
Baby
Nighttime
Cold & Cough ^*

CHAMOMILLA 6X HPUS
Occasional sleeplessness

EUPATORIUM PERFOLIATUM 6X HPUS
Headache, cough, sneezing

EUPHRASIA OFFICINALIS 6X HPUS
Runny eyes and nose

GELSEMIUM SEMPERVIRENS 6X HPUS
Sneezing with stuffy nose

KALI IODATUM 6X HPUS
Headache, runny eyes and nose

Relief Of:
Runny nose, congestion and
occasional sleeplessness
due to colds

Alcohol Free
No Artificial Flavors,
Dyes or Parabens

4 FL OZ (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69842-411-01	2021-08-03	C162847	48780-1	c7ccaba7-1cf8-fd44-e053-dadaa90aa01b	CVS Baby Nighttime Cold and Cough
69842-411-01	2021-07-23	C162847	48780-1	c7ccaba7-1cf8-fd44-e053-dadaa90aa01b	CVS Baby Nighttime Cold and Cough

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

CVS Baby Nighttime Cold and Cough
Matricaria Recutita, Eupatorium Perfoliatum Flowering Top, Euphrasia Stricta, Gelsemium Sempervirens Root, And Potassium Iodide
CITRIC ACID MONOHYDRATE
GLYCERIN
LICORICE
WATER
SODIUM BENZOATE
MATRICARIA RECUTITA
EUPATORIUM PERFOLIATUM FLOWERING TOP
EUPHRASIA STRICTA
GELSEMIUM SEMPERVIRENS ROOT
POTASSIUM IODIDE
IODIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69842-411	69842-411-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCERIN	PDC6A3C0OX	IACT
LICORICE	61ZBX54883	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
MATRICARIA RECUTITA	G0R4UBI2ZZ	ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP	1W0775VX6E	ACTIB
EUPHRASIA STRICTA	C9642I91WL	ACTIB
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB
POTASSIUM IODIDE	1C4QK22F9J	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
087a0270-6027-7531-e063-6394a90ae0c3			821efebb-5ac8-4f70-a221-25d6eeda43ff	2023-10-24	Warnings	Exact identifier spl set id: 821efebb-5ac8-4f70-a221-25d6eeda43ff

Reported adverse events (FAERS/openFDA)#

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