4 Kids Cold and Cough Nighttime: Homeopathic Product Information

4 KIDS COLD AND COUGH NIGHTTIME- onion, calcium sulfide, sodium chloride, anemone pulsatilla, matricaria chamomilla, goldenseal, arabica coffee bean, phosphorus and sulfur liquid
Hyland’s

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Facts

Active ingredients

Purpose

Allium Cepa 6X HPUS

watery/runny nose, cold, hacking cough, painful throat

Chamomilla 6X HPUS

sensitive, irritable, fussy, nocturnal occasional sleeplessness

Coffea Cruda 6X HPUS

occasional sleeplessness, restlessness

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, post nasal drip

Sulphur 12X HPUS

chest congestion, nasal congestion, sneezing, runny nose

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

Uses

■Temporarily relieves symptoms of common cold in children at night, including:

■ cough ■ runny nose ■ post nasal drip

■ sneezing ■ nasal or chest congestion

■ sore throat ■ occasional sleeplessness

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. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

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 at bedtime and every

4 hours during the night

until relieved

Children 6 years

to under 12 years

10 mL at bedtime and every

4 hours during the night

until relieved

Adults and

children 12 years

and over

15 mL at bedtime and every

4 hours during the night

until relieved

Other information

  • Do not use if imprinted “Lift ‘n’ Peel™” tamper-evident bottle mouth foil seal 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

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

PRIMARY DISPLAY PANEL

HOMEOPATHIC

NDC 54973-3375-1

2-12

YEARS

NEW

LOOK

4 KIDS

SINCE 1903

Hyland’s

NIGHTTIME

Cold &

Cough*

Relieves congestion,

runny nose, sore throat,

sneezing, cough, post nasal drip

and occasional sleeplessness

NO ALCOHOL or PARABENS

NO SUGAR or DYES

NATURAL

RELIEF

4 FL. OZ. (118 mL)

*SEE NOTE ON SIDE PANEL BELOW DRUG FACTS

carton
(click image for full-size original)
4 KIDS COLD AND COUGH NIGHTTIME
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3375
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ONION (ONION) ONION 6 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 6 [hp_X] in 1 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 6 [hp_X] in 1 mL
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN 6 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL
SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCYRRHIZA GLABRA
GLYCERIN
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3375-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3375-1)
2 NDC:54973-3375-2 5 mL in 1 PACKET None
3 NDC:54973-3375-3 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
3 148 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (54973-3375-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/01/2018
Labeler — Hyland’s (028570695)
Registrant — Standard Homeopathic Company (Hyland’s) (008316655)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma, Inc. 079424083 manufacture (54973-3375), pack (54973-3375), label (54973-3375)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 080253323 manufacture (54973-3375), pack (54973-3375), label (54973-3375)
Establishment
Name Address ID/FEI Operations
Applied Laboratories, Inc. 876754375 manufacture (54973-3375), pack (54973-3375), label (54973-3375)

Revised: 05/2020 Hyland’s

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