COUGH BABY- ipecac, bryonia alba root, spongia officinalis skeleton, roasted, phosphorus, causticum, drosera rotundifolia, and rumex crispus root syrup 
Hyland's Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Hyland's Naturals Baby Cough Syrup Daytime

Relieves coughs in babies

Drug Facts

Active ingredients

Purpose

Bryonia Alba 6X HPUS

dry cough

Causticum 6X HPUS

hoarse cough

Drosera Rotundifolia 6X HPUS

barking cough

Ipecacuanha 6X

gagging cough

Phosphorus 12X HPUS

tight cough

Rumex Crispus 6X HPUS

dry cough

Spongia Tosta 6X HPUS

tickling cough

"HPUS" indicates that the active ingredients are in the official Homeopathic

Pharmacopoeia of the United States.

Uses

■ Temporarily relieves the symptoms of simple, dry, tight or tickling coughs due to colds in children.

Warnings

Ask a doctor before use if you have:

■ persistent or chronic cough such as asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if:

■ symptoms persist for more than 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

Keep out of reach of children.

Keep this and all medications out of the reach of children.

Directions

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.  Measure
only with the dosing syringe provided. ■ Do not use dosing syringe with other
products. ■ On dosing syringe, mL = milliliter.

Children under 6 monthsAsk a doctor before use.
Children 6 months to under 1 year2.5 mL up to 4 times per day (every 6 hours).
Children 1 year to under 3 years5 mL up to 6 times per day (every 4 hours).

Inactive ingredients

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

Questions?

(800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,
NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

PACKAGE LABEL-118 mL BOTTLE CARTON

Hyland's

NATURALS™

•baby•

Cough

Syrup*

DAYTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

6+ MONTHS

4 FL. OZ. (118 mL)

HOMEOPATHIC

Carton

COUGH BABY 
ipecac, bryonia alba root, spongia officinalis skeleton, roasted, phosphorus, causticum, drosera rotundifolia, and rumex crispus root syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3154
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC6 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED6 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM6 [hp_X]  in 1 mL
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA6 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LICORICE (UNII: 61ZBX54883)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3154-2118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2012
2NDC:54973-3154-119.81 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/17/201212/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/17/2012
Labeler - Hyland's Inc. (008316655)

Revised: 12/2022
Document Id: efa3be17-4614-b709-e053-2a95a90a6dcf
Set id: 2daac16d-69d0-48bf-806f-f22c0a6973ad
Version: 10
Effective Time: 20221212
 
Hyland's Inc.