Label: CHILDRENS NIGHTTIME COLD AND COUGH- onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride liquid
- NDC Code(s): 49035-920-01
- Packager: Wal-Mart Stores, Inc
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated July 5, 2018
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Drug Facts
Active ingredients
Active ingredients
Purpose
Allium Cepa 6X HPUS
watery/runny nose, cold, hacking cough, sore 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, nasal congestion
Sulphur 12X HPUS
chest congestion, nasal congestion, sneezing, runny nose
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
- Uses
-
Drug Facts (continued)
Warnings
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 health care professional.
-
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 ery
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
-
Principal Display Panel - 118 mL Bottle Label
NDC 49035-920-01
Compare to
Hyland's 4 Kids
Cold 'n Cough
Nighttime
Equate™
Alcohol Free, Sugar Free, Dye Free
Homeopathic
Childrens
Cold & Cough*
Nighttime
AGES 2 to 12 YEARS
For Temporary Relief of:
Chest congestion
Occasional sleeplessness
Runny nose
Sore throat
Cough
4 FL OZ (118mL)
*Claims based on traditional homeopathic
practice, not accepted medical evidence.
Not FDA evaluated.
-
INGREDIENTS AND APPEARANCE
CHILDRENS NIGHTTIME COLD AND COUGH
onion, arabica coffee bean, calcium sulfide, phosphorus, matricaria chamomilla, anemone pulsatilla, goldenseal, sulfur and sodium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-920 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-920-01 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/02/2018 Labeler - Wal-Mart Stores, Inc (051957769) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(49035-920) , pack(49035-920) , label(49035-920) Establishment Name Address ID/FEI Business Operations NEXGEN PHARMA, INC. 079424083 manufacture(49035-920) , pack(49035-920) , label(49035-920) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 117337220 manufacture(49035-920) , pack(49035-920) , label(49035-920)