4 Kids Daytime Cold 'n Mucus

4 Kids Daytime Cold 'n Mucus
SPL v11
SPL
SPL Set ID ef39fe3d-a42d-4baa-9199-91f664feb432
Route
ORAL
Published
Effective Date 2016-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bryonia Alba Root (6 [hp_X]) Euphrasia Stricta (12 [hp_X]) Calcium Sulfide (30 [hp_X]) Chloride Ion Phosphorus Anemone Pulsatilla Rumex Crispus Root Silicon Dioxide
Inactive Ingredients
Citric Acid Monohydrate Glycyrrhiza Glabra Water Sodium Benzoate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-07-01 Until 2021-12-15

Description

Relieves mucus, congestion, cough, runny nose and sneezing

Dosage and Administration

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).


Medication Information

Dosage and Administration

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).

Description

Relieves mucus, congestion, cough, runny nose and sneezing

Uses

■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose

■ cough with expectoration of thick, discolored mucus

■ runny nose ■ sneezing ■ nasal or chest congestion

Section 34088-5

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Section 42229-5

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

Section 43683-2

PDP - updated natural relief icon, applied new Hyland's logo, added 'daytime' beneath the product

name, updated illustration pants to navy blue, scrubbed packaging of spanish copy. Right Panel - updated benefits to: 'our

formulas are safe and always:' (removed mention of effective). Left Panel - updated cross sell section and HPUS

disclaimer. Drug Facts - Revised 'Consult a physician' and added 'sore throat warning' statement to match our Cold 'n

Mucus Nighttime/Cold 'n Cough SKUs (daytime/nighttime), updated tamper-evident statement to: Do not use if imprinted tamper-evident bottle band is broken or missing. Added the following statement before 'in case of emergency': The inner packaged bottle is child-resistant.

Temporarily relieves symptoms of common cold in children, including: accumulation of mucus in chest, throat or nose cough with expectoration of thick, discolored mucus runny nose  sneezing  nasal or chest congestion

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

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.

Section 53414-9

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

Section 55105-1

Relieves mucus, congestion, cough, runny nose and sneezing

Section 55106-9
Active ingredients Purpose
Bryonia 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 the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Directions

■ Measure only with the dosing cup provided

■ Do not use dosing cup with other products

■ On dosing cup, mL = milliliter, tsp = teaspoon

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).

Drug Facts

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.

Questions Or Comments?

(800) 624-9659

Principal Display Panel 118 Ml Bottle Carton

HOMEOPATHIC

NDC 54973-3179-1



2-12

YEARS

New

Look

4 Kids

SINCE 1903

Hyland's ®

DAYTIME

Cold &

Mucus
*

Relieves mucus,

congestion, cough,

runny nose and sneezing

NO ALCOHOL or PARABENS

NO SUGAR or DYES

NATURAL

RELIEF

4 FL. OZ. (118 mL)

*SEE NOTE

ON SIDE PANEL

BELOW DRUG FACTS


Structured Label Content

Uses

■Temporarily relieves symptoms of common cold in children, including: ■ accumulation of mucus in chest, throat or nose

■ cough with expectoration of thick, discolored mucus

■ runny nose ■ sneezing ■ nasal or chest congestion

Section 34088-5 (34088-5)

In case of emergency or accidental overdose, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Section 42229-5 (42229-5)

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

Section 43683-2 (43683-2)

PDP - updated natural relief icon, applied new Hyland's logo, added 'daytime' beneath the product

name, updated illustration pants to navy blue, scrubbed packaging of spanish copy. Right Panel - updated benefits to: 'our

formulas are safe and always:' (removed mention of effective). Left Panel - updated cross sell section and HPUS

disclaimer. Drug Facts - Revised 'Consult a physician' and added 'sore throat warning' statement to match our Cold 'n

Mucus Nighttime/Cold 'n Cough SKUs (daytime/nighttime), updated tamper-evident statement to: Do not use if imprinted tamper-evident bottle band is broken or missing. Added the following statement before 'in case of emergency': The inner packaged bottle is child-resistant.

Temporarily relieves symptoms of common cold in children, including: accumulation of mucus in chest, throat or nose cough with expectoration of thick, discolored mucus runny nose  sneezing  nasal or chest congestion

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)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Relieves mucus, congestion, cough, runny nose and sneezing

Section 55106-9 (55106-9)
Active ingredients Purpose
Bryonia 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 the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Directions

■ Measure only with the dosing cup provided

■ Do not use dosing cup with other products

■ On dosing cup, mL = milliliter, tsp = teaspoon

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).

Drug Facts

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.

Questions Or Comments? (Questions or comments?)

(800) 624-9659

Dosage and Administration

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).

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

HOMEOPATHIC

NDC 54973-3179-1



2-12

YEARS

New

Look

4 Kids

SINCE 1903

Hyland's ®

DAYTIME

Cold &

Mucus
*

Relieves mucus,

congestion, cough,

runny nose and sneezing

NO ALCOHOL or PARABENS

NO SUGAR or DYES

NATURAL

RELIEF

4 FL. OZ. (118 mL)

*SEE NOTE

ON SIDE PANEL

BELOW DRUG FACTS


Advanced Ingredient Data


Raw Label Data

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