Equate Children’s Cold & Cough Day & Night Value Pack

Equate Children’s Cold & Cough Day & Night Value Pack
SPL v7
SPL
SPL Set ID 70454f5a-b5ca-8d30-e053-2991aa0a1afc
Route
ORAL
Published
Effective Date 2018-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-07-01

Description

Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, sore 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 2 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 2 teaspoon

Description

Active ingredients Purpose Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, sore 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

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 50565-1

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

Section 50569-3

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
Section 50570-1

In case of emergency or accidental overdose,

contact a medical professional or Poison Control

Center immediately.

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, sore 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.

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.

Drug Facts

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 over

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, Glycerin, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

Primary Principal Display Panel Children's Cold & Cough Day & Night Value Pack

VALUE PACK

NDC 49035-95-01

Equate™

Compare to

Hyland’s 4 Kids

Cold ‘n Cough Day

& Night Value Pack

active ingredients

Children's

Alcohol-Free, Sugar-Free Dye-Free

Homeopathic

Cold & Cough*

Daytime

Ages 2 to12 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 (118mL) Daytime

8 FL OZ (236mL) TOTAL

Children's

Alcohol-Free, Sugar-Free Dye-Free

Homeopathic

Cold & Cough*

Nighttime

Ages 2 to12 years

For Temporary Relief of:

  • Chest congestion
  • Occasional sleeplessness
  • Runny nose
  • Sore throat
  • Sneezing
  • Cough

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

4 FL OZ (118mL) Nighttime


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)

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 50565-1 (50565-1)

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

In case of emergency or accidental overdose,

contact a medical professional or Poison Control

Center immediately.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Allium Cepa 6X HPUS watery/runny nose, cold, hacking cough, sore 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.

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.

Drug Facts

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 over

15mL 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, Glycerin, 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 2 teaspoon

Primary Principal Display Panel Children's Cold & Cough Day & Night Value Pack (Primary Principal Display Panel - Children's Cold & Cough Day & Night Value Pack)

VALUE PACK

NDC 49035-95-01

Equate™

Compare to

Hyland’s 4 Kids

Cold ‘n Cough Day

& Night Value Pack

active ingredients

Children's

Alcohol-Free, Sugar-Free Dye-Free

Homeopathic

Cold & Cough*

Daytime

Ages 2 to12 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 (118mL) Daytime

8 FL OZ (236mL) TOTAL

Children's

Alcohol-Free, Sugar-Free Dye-Free

Homeopathic

Cold & Cough*

Nighttime

Ages 2 to12 years

For Temporary Relief of:

  • Chest congestion
  • Occasional sleeplessness
  • Runny nose
  • Sore throat
  • Sneezing
  • Cough

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

4 FL OZ (118mL) Nighttime


Advanced Ingredient Data


Raw Label Data

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