INFANTS COUGH SYRUP- drosera rotundifolia, bryonia alba, ipecacuanha, spongia tosta, causticum, phosphorus, rumex crispus syrup

INFANTS COUGH SYRUP by

Drug Labeling and Warnings

INFANTS COUGH SYRUP by is a Homeopathic medication manufactured, distributed, or labeled by CVS PHARMACY, HOMEOLAB USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients HPUS*

Drosera rotundifolia 6X

Bryonia alba 6X

Ipecacuanha 6X

Spongia tosta 6X

Causticum 6X

Phosphorus 12X

Rumex crispus 6X

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

Purpose

Drosera rotundifolia 6X................................ Barking cough

Bryonia alba 6X.......................................... Dry cough

Ipecacuanha 6X.......................................... Gagging cough

Spongia tosta 6X......................................... Tickling cough 

Causticum 6X............................................. Hoarse cough

Phosphorus 12X.......................................... Tight cough

Rumex crispus 6X....................................... Dry cough

Uses

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

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Warnings

As with any drug, ask a doctor before use if pregnant or nursing.

Stop use and ask a doctor if  symptoms persist for more than 48 hours or worsen cough tends to recur or is accompanied by a high fever, rash or persistent headache.

Keep this and all medications out of the reach of children. In case of emergency or accidental overdose, contact a medical professional or a poison control center immediately.

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema, or 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.

Do not use if seal under bottle cap is broken or missing.

Directions

Measure only with the dosing syringe provided.

Do not use dosing syringe with other products.

On dosing syringe, tsp = teaspoon.

Children under 6 months of age: Consult a licensed health care professional before using this product.

Children 6 months to 1 year of age:  2.5 ml or 1/2 teaspoon up to 4 times a day (every 6 hours), or as directed by a licensed health care professional.

Children 1 to 3 years of age:  5 ml or 1 teaspoon up to 6 times a day (every 4 hours), or as directed by a licensed health care professional.

Other information

Store at room temperature (68°-77°F).

Inactive ingredients

Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INFANTS COUGH SYRUP 
drosera rotundifolia, bryonia alba, ipecacuanha, spongia tosta, causticum, phosphorus, rumex crispus syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-347
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ)	DROSERA ROTUNDIFOLIA	6 [hp_X]  in 100 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]  in 100 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	6 [hp_X]  in 100 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	6 [hp_X]  in 100 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	6 [hp_X]  in 100 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 100 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-347-02	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/21/2014

Labeler - CVS PHARMACY (062312574)

Registrant - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(59779-347)