CHILDRENS COLD AND COUGH NIGHTTIME- onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid 
Walgreen Company

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.

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Walgreens Children's Nighttime Dye-Free Cold & Cough

Drug Facts

Active ingredients

Allium Cepa 6X HPUS

Chamomilla 6X HPUS

Coffea Cruda 6X HPUS

Hepar Sulph Calc 12X HPUS

Hydrastis 6X HPUS

Natrum Muriaticum 6X HPUS

Phosphorus 12X HPUS

Pulsatilla 6X HPUS

Sulphur 12X HPUS

“HPUS” indicates that the active ingredients are in the official Homeopathic

Pharmacopœia of the United States.

Purpose

Allium Cepa 6X HPUS...................watery/runny nose, cold, hacking cough, sore throat

Chamomilla 6X HPUS...................sensitive, irritable, fussy, 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, 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 or chest congestion or sore throat with accompanying occasional sleeplessness.

Drug Facts (continued)

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.

In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

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

contact a medical professional or Poison Control Center immediately.

Directions

Children 2 years

to under 6 years

5 mL at bedtime and every 4 hours

during the night or as necessary

Children 6 years

to under 12 years

10 mL at bedtime and every 4 hours

during the night or as necessary

Adults and children

12 years and over

15 mL at bedtime and every 4 hours

during the night or as necessary

Other information

Inactive ingredients

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

Questions or comments?

1-800-925-4733

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,

NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Principal Display Panel - 118 mL Bottle Label

Walgreens

NDC 0363-9996-01

children's

Nighttime

Dye-Free

Cold & Cough*

DYE FREE SUGAR FREE

ALCOHOL FREE

AGES

2-12

YEARS

FLAVOR FREE

4 FL OZ (118 mL)

Label

CHILDRENS COLD AND COUGH NIGHTTIME 
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9996
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA6 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN6 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9996-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/01/2019
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655pack(0363-9996) , manufacture(0363-9996) , label(0363-9996)

Revised: 12/2022
Document Id: efe0ec6b-9901-858f-e053-2a95a90aec59
Set id: 80c41b65-0411-4395-e053-2a91aa0a9df9
Version: 5
Effective Time: 20221215
 
Walgreen Company