Nighttime Cold n Cough 4 Kids description, usages, side effects, indications, overdosage, supplying and lots more!

Nighttime Cold n Cough 4 Kids

Hyland's, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients Purpose
Allium Cepa 6X HPUS watery runny nose, cold, hacking cough, painful throat
Coffea Cruda 6X HPUS sleeplessness, restlessness
Chamomilla 6X HPUS sensitive, irritable, fussy, nocturnal sleeplessness
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

Uses

  • Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying 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 a high fever (101° F)
  • Cough tends to recur or is accompanied by a high fever, rash or persistent headache.

Keep this and all medications out of 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 health care professional. In case of accidental overdose, contact a poison control center immediately.

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

Do not use if imprinted tamper band is broken or missing. In case of accidental overdose, contact a poison control center immediately. In case of emergency, Hyland's may be contacted 24 hours a day, 7 days a week at 800/624-9659.

There have been no reports of interactions between this product and ibuprofen or acetaminophen.

Directions

Children 2 to under 6 years: 5 mL or 1 teaspoon at bedtime, and every 4 hours during the night or as necessary.

Children 6 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.

Inactive Ingredients

Purified Water USP, Vegetable Glycerine USP, Citric Acid USP, Sodium Benzoate N.F., Glycyrrhiza Extract.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Hyland's ®

NDC 54973-3098-01
HOMEOPATHIC

Nighttime
Cold'n
Cough
4
KIDS

100%
Natural

Safe & Effective

Safe Age 2+

4 FL. OZ.
(118 mL.) MADE IN USA

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

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 label Item Code (Source) NDC:54973-3098
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ONION ONION 6 [hp_X]
COFFEE BEAN COFFEE BEAN 6 [hp_X]
CHAMOMILE CHAMOMILE 6 [hp_X]
CALCIUM SULFIDE CALCIUM CATION 12 [hp_X]
GOLDENSEAL GOLDENSEAL 6 [hp_X]
SODIUM CHLORIDE 6 [hp_X]
STRYCHNOS NUX-VOMICA SEED STRYCHNOS NUX-VOMICA SEED 6 [hp_X]
PHOSPHORUS PHOSPHORUS 12 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 6 [hp_X]
SULFUR SULFUR 12 [hp_X]

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCYRRHIZA GLABRA
water
SODIUM BENZOATE
GLYCERIN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54973-3098-1 118 in 1 BOTTLE, PLASTIC
2 NDC:54973-3098-2 19.8 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-07-01


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