COUGH AND MUCUS GRAPE FLAVOR- antimony potassium tartrate,bryonia alba root,ferrosoferric phosphate,calcium sulfide,ipecac,phosphorus,anemone pulsatilla,rumex crispus root liquid

Cough and Mucus Grape Flavor by

Drug Labeling and Warnings

Cough and Mucus Grape Flavor by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

• Active ingredients: Purpose
• Antimonium Tartaricum 15X HPUS: cough
• Bryonia Alba 15X HPUS: sore throat, mucus in throat, cough
• Ferrum Phosphoricum 12X HPUS: mucus in throat, cough
• Hepar Sulph Calc 12X HPUS: mucus in chest, cough
• Ipecacuanha 12X HPUS: cough, sore throat
• Phosphorus 15X HPUS: runny nose, chest or nasal congestion
• Pulsatilla 12X HPUS: mucus in chest or throat, cough, sneezing
• Rumex Crispus 6X HPUS: runny nose, sneezing

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

■ Helps temporarily relieve symptoms of common cold in children, including: ■ cough ■ runny nose ■ sneezing ■ sore throat
■ chest or nasal congestion ■ mucus in chest or throat

Warnings

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

■ persistent or chronic cough such as smoking, 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 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

Ask a health professional before use.

Keep out of reach of children

Directions

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

• Children 2 years to under 6 years: 5 mL up to 6 times per day ; (every 4 hours).
• Children 6 years to under 12 years: 10 mL up to 6 times per day ; (every 4 hours).
• Adults and children 12 years and over: 15 mL up to 6 times per day ; (every 4 hours).

Inactive ingredients

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

Questions?

www.hylands.com or care@hylands.com

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

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

PURPOSE

■ Helps temporarily relieve symptoms of common cold in children, including: ■ cough ■ runny nose ■ sneezing ■ sore throat ■ chest or nasal congestion ■ mucus in chest or throat

Principal Display Panel

Hyland's

NATURALS™

Kids

Cough &

Mucus*

DAYTIME

NO ALCOHOL, SUGAR,

PARABEN or DYES

Cough

Mucus

Congestions

Runny Nose

EFFECTIVE

MUCUS

RELIEF

2-12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

COUGH AND MUCUS 5OZ

INGREDIENTS AND APPEARANCE

COUGH AND MUCUS GRAPE FLAVOR 
antimony potassium tartrate,bryonia alba root,ferrosoferric phosphate,calcium sulfide,ipecac,phosphorus,anemone pulsatilla,rumex crispus root liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4056
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X]  in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	12 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	12 [hp_X]  in 1 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5)	ANTIMONY POTASSIUM TARTRATE	15 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4056-1	1 in 1 CARTON	03/01/2022
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 54973-4056-2	1 in 1 CARTON	03/01/2022
2		148 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		03/01/2022

Labeler - Hyland's Inc. (008316655)

Establishment
Name	Address	ID/FEI	Business Operations
Hyland's Inc.		008316655	manufacture(54973-4056) , pack(54973-4056) , label(54973-4056)