COLD AND MUCUS- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid

Cold and Mucus by

Drug Labeling and Warnings

Cold and Mucus 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

• Bryonia Alba 6X HPUS:

  stubborn mucus in throat, cough with yellowish mucus

• Euphrasia Officinalis 6X HPUS:

  cough with mucus in chest

• Hepar Sulph Calc 12X HPUS:

  cough up mucus, mucus rattle with cough, stubborn mucus in chest

• Natrum Muriaticum 30X HPUS:

  accumulation of mucus in throat, cough up mucus

• Phosphorus 30X HPUS:

  cough with expectoration of yellow mucus, chest congestion

• Pulsatilla 6X HPUS:

  accumulation of mucus, discharge of thick yellowish mucus, loose cough

• Rumex Crispus 6X HPUS:

  runny nose, sneezing

• Silicea 12X HPUS:

  nasal congestion

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

Uses

Temporarily relieves symptoms of colds,including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

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 high fever (101°F)
• Cough tends to recur or is accompanied by 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.

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:

  5mL up to 6 times per day

  (every 4 hours)

• Children 6 years to under 12 years:

  10mL up to 6 times per day

  (every 4 hours)

• Adults and children 12 years and under:

  15mL 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.

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

NDC: 49035-926-01

Equate™

Compare to

Hyland’s 4 Kids

Cold ’n Mucus

Alcohol Free, Sugar Free, Dye Free

Homeopathic

Children's

Cold & Mucus*

Daytime

AGES 2 to 12 YEARS

For Temporary Relief of:

• Mucus & Congestion

• Runny Nose

• Cough

*Claims based on traditional

homeopathic practice, not

accepted medical evidence.

Not FDA evaluated.

4 FL OZ (118 mL)

INGREDIENTS AND APPEARANCE

COLD AND MUCUS 
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-926
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X]  in 1 mL
RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C)	RUMEX CRISPUS ROOT	6 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-926-01	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(49035-926) , pack(49035-926) , label(49035-926)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(49035-926) , pack(49035-926) , label(49035-926)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		117337220	manufacture(49035-926) , pack(49035-926) , label(49035-926)