Equate Children's Cold & Cough Daytime

Equate Children's Cold & Cough Daytime
SPL v5
SPL
SPL Set ID 69349b4d-6c5b-7121-e053-2991aa0a3594
Route
ORAL
Published
Effective Date 2018-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Onion (6 [hp_X]) Calcium Sulfide (12 [hp_X]) Phosphorus Anemone Pulsatilla Sulfur Sodium Cation Goldenseal
Inactive Ingredients
Glycyrrhiza Glabra Citric Acid Monohydrate Water Sodium Benzoate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-06-01

Description

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.

Dosage and Administration

 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. removed Teaspoon


Medication Information

Dosage and Administration

 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.

removed Teaspoon

Description

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.

Section 42229-5

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

Section 50565-1

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

Section 50570-1

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.

Section 55105-1
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.

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
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.

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)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

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.

Section 55105-1 (55105-1)
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.

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
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 (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 (Inactive ingredients)

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

Dosage and Administration

 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.

removed Teaspoon

Principal Display Panel 4 Fl Oz (118 Ml) Bottle Carton (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)


Advanced Ingredient Data


Raw Label Data

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