CVS BABY NIGHTTIME COLD AND COUGH- matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid

CVS Baby Nighttime Cold and Cough by

Drug Labeling and Warnings

CVS Baby Nighttime Cold and Cough by is a Homeopathic medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

Warnings

Do not use

• 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

• 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

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

Directions

• 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

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

Inactive ingredients

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

♥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)

INGREDIENTS AND APPEARANCE

CVS BABY NIGHTTIME COLD AND COUGH 
matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-411
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X]  in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X]  in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
LICORICE (UNII: 61ZBX54883)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-411-01	1 in 1 CARTON	02/10/2017
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/10/2017

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	MANUFACTURE(69842-411) , PACK(69842-411) , LABEL(69842-411)

Establishment
Name	Address	ID/FEI	Business Operations
NEXGEN PHARMA, INC.		079424083	MANUFACTURE(69842-411) , PACK(69842-411)