COLD AND COUGH- onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Cold and Cough by

Drug Labeling and Warnings

Cold and Cough by is a Homeopathic medication manufactured, distributed, or labeled by  Wal-Mart Stores, Inc. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

• Active ingredients: Purpose
• Allium Cepa 6X HPUS: watery/runny nose, cold, hacking cough, painful throat
• Hepar Sulph Calc 12X HPUS: cold, sneezing
• Hydrastis 6X HPUS: rattling/tickling cough, sinus congestion, dry/raw/sore throat
• Natrum Muriaticum 6X HPUS: dry cough, sore throat
• Phosphorus 12X HPUS:

  hoarse/dry cough, nasal congestion, chest congestion

• Pulsatilla 6X HPUS: moist cough, cold, nasal congestion
• Sulphur 12X HPUS: chest congestion, nasal congestion, sneezing, runny nose

"HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.

Warnings

As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if:

• Symptoms persist for more than 7 days or worsen
• Inflammation, fever or infection develops
• Symptoms are accompanied by a high fever (over 101°F)
• 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.

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 medical professional.

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

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache,nausea and vomiting may be serious. Consult a doctor promptly.

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately.

Drug Facts (continued)

Directions

• 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)

Other information

• Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
• The inner packaged bottle is child-resistant.
• Store at room temperature.
• Do not refrigerate.

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Principal Display Panel - 4 FL OZ (118 mL) Bottle Carton

NDC: 49035-927-01

Equate™

Compare to

Hyland’s 4 Kids

Cold ’n Cough

active

ingredients

Children's

Alcohol Free, Sugar Free, Dye Free

Homeopathic

Cold & Cough*

Daytime

AGES 2 to 12 YEARS

For Temporary Relief of:

• Nasal Congestion

• Runny Nose

• Sore Throat

• Sneezing

• Cough

*Claims based on traditional

homeopathic practice, not

accepted medical evidence.

Not FDA evaluated.

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

COLD AND COUGH 
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-927
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	6 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-927-01	1 in 1 CARTON	06/01/2018
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		06/01/2018

Labeler -  Wal-Mart Stores, Inc.  (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(49035-927) , pack(49035-927) , label(49035-927)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(49035-927) , pack(49035-927) , label(49035-927)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(49035-927) , pack(49035-927) , label(49035-927)