Label: 4 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR- onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean kit
- NDC Code(s): 54973-3243-1, 54973-3377-1, 54973-3379-1
- Packager: Hyland's 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 November 18, 2022
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- Official Label (Printer Friendly)
- PURPOSE
-
DAYTIME
Drug Facts
Active ingredients
Purpose
Allium Cepa 6X HPUS
watery/runny nose, cold, hacking cough, painful throat
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
Uses
■ Temporarily relieves symptoms of common cold
in children, including:
■ runny nose ■ sore throat ■ sneezing
■ cough ■ post nasal drip
■ nasal or chest congestionWarnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly.Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).
Directions
■ Use as directed. ■ Do not refrigerate. ■ 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 years5 mL up to 6 times per day
(every 4 hours).Children 6 years
to under 12 years10 mL up to 6 times per day
(every 4 hours).Adults and children
12 years and over15 mL up to 6 times per day
(every 4 hours). -
NIGHTTIME
Drug Facts
Active ingredients
Purpose
Allium Cepa 6X HPUS
watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS
occasional sleeplessness
Coffea Cruda 6X HPUS
occasional 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
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
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 sleeplessnessWarnings
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,
rash, nausea, or vomiting, consult a doctor promptly.Ask a doctor before use if you have: ■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).
Directions
■ Use as directed. ■ Do not refrigerate. ■ 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 years5 mL at bedtime and every 4 hours
during the night until relieved.Children 6 years
to under 12 years10 mL at bedtime and every 4 hours
during the night until relieved.Adults and children
12 years and over15 mL at bedtime and every 4 hours
during the night until relieved. - SPL UNCLASSIFIED SECTION
- OTHER SAFETY INFORMATION
-
PACKAGE LABEL - KIT CARTON
Hyland's
NATURALS™
•KIDS•
Cold & Cough
COMBO PACK
NO ALCOHOL, SUGAR,
PARABENS or DYES
DAYTIME
Congestion
Runny Nose
Sore Throat
Cough
Post Nasal
Drip
NIGHTTIME
Sleeplessness
Congestion
Runny Nose
Sore Throat
Cough
Post Nasal
Drip
2-12 YEARS
NATURAL
GRAPE FLAVOR
TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night) | TOTAL 8 FL. OZ. (236 ML)
HOMEOPATHIC
-
INGREDIENTS AND APPEARANCE
4 KIDS COLD AND COUGH DAY AND NIGHT GRAPE FLAVOR
onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3379 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3379-1 1 in 1 CARTON; Type 0: Not a Combination Product 12/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 118 mL Part 2 1 BOTTLE, PLASTIC 118 mL Part 1 of 2 4 KIDS COLD N COUGH GRAPE FLAVOR
onion, calcium sulfide, goldenseal, sodium chloride, phosphorus, anemone pulsatilla, and sulfur liquidProduct Information Item Code (Source) NDC:54973-3243 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 GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3243-1 1 in 1 CARTON 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/10/2016 Part 2 of 2 4 KIDS COLD AND COUGH NIGHTTIME NATURAL GRAPE FLAVOR
onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean liquidProduct Information Item Code (Source) NDC:54973-3377 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 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 ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3377-1 1 in 1 CARTON 1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2018 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3379) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc 117337220 manufacture(54973-3379) , pack(54973-3379) , label(54973-3379)