Nighttime Cold N Cough 4 Kids: Homeopathic Product Information

NIGHTTIME COLD N COUGH 4 KIDS- sodium chloride, strychnos nux-vomica seed, phosphorus, anemone pulsatilla, sulfur, onion, coffee bean, chamomile, calcium sulfide and goldenseal 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

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

Nux Vomica 6X HPUS

tired, difficulty falling asleep, frequent waking
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 the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

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

Warnings

As with any drug, ask a doctor before use if pregnant or nursing. 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

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.

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.

Do not use if imprinted tamper band is broken or missing.

Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Drug Facts (continued)

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 or 1 teaspoon at bedtime and every 4 hours during the night or as necessary
Children 6 years to under 12 years 10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
Adults and children 12 years and over 15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

In case of emergency, 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.

Inactive ingredients

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

Questions or comments?

(800) 624-9659

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

PRINCIPAL DISPLAY PANEL — 118 mL Bottle Carton

NDC 54973-3098-1
HOMEOPATHIC

Natural

Relief

Ages 2-12

SINCE 1903
Hyland’s ®
4 Kids

Cold ‘n
Cough*
NIGHTTIME

Chest Congestion
Occasional Sleeplessness
Runny Nose
Sore Throat
Sneezing
Cough

ALCOHOL FREE
SUGAR FREE
DYE FREE

SAFE & EFFECTIVE

4 FL. OZ. (118 mL)

Carton
(click image for full-size original)
NIGHTTIME COLD N COUGH 4 KIDS
onion, coffee bean, chamomile, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, and sulfur liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3098
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE 6 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 6 [hp_X] in 1 mL
PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 12 [hp_X] in 1 mL
ANEMONE PULSATILLA (ANEMONE PULSATILLA) ANEMONE PULSATILLA 6 [hp_X] in 1 mL
SULFUR (SULFUR) SULFUR 12 [hp_X] in 1 mL
ONION (ONION) ONION 6 [hp_X] in 1 mL
COFFEE BEAN (COFFEE BEAN) COFFEE BEAN 6 [hp_X] in 1 mL
CHAMOMILE (CHAMOMILE) CHAMOMILE 6 [hp_X] in 1 mL
CALCIUM SULFIDE (CALCIUM SULFIDE) CALCIUM SULFIDE 12 [hp_X] in 1 mL
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL 6 [hp_X] in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCYRRHIZA GLABRA
WATER
SODIUM BENZOATE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54973-3098-1 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:54973-3098-2 19.8 mL in 1 BOTTLE, PLASTIC None
3 NDC:54973-3098-3 5 mL in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/01/2010
Labeler — Hyland’s (028570695)
Establishment
Name Address ID/FEI Operations
Standard Homeopathic Company 008316655 manufacture (54973-3098), pack (54973-3098)
Establishment
Name Address ID/FEI Operations
Applied Laboratories, Inc. 117337220 manufacture (54973-3098), pack (54973-3098)
Establishment
Name Address ID/FEI Operations
LGM Pharma Solutions, LLC 117549198 manufacture (54973-3098), pack (54973-3098), label (54973-3098)
Establishment
Name Address ID/FEI Operations
Lifetech Resources 622559110 manufacture (54973-3098), pack (54973-3098)

Revised: 07/2021 Hyland’s

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