Label: BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME- calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla kit
- NDC Code(s): 54973-3284-1, 54973-3371-2, 54973-3374-1
- Packager: Hyland's Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 August 23, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
DAYTIME
Drug Facts
Active ingredients Purpose* Bryonia Alba 6X HPUS stubborn mucus in throat, cough with mucus Euphrasia Officinalis 6X HPUS cough with mucus in chest Hepar Sulph Calc 12X HPUS cough up mucus, mucus rattle with cough, stubborn mucus in chest Natrum Muriaticum 30X HPUS accumulation of mucus in throat, cough up mucus Phosphorus 30X HPUS cough with mucus, chest congestion Pulsatilla 6X HPUS accumulation of mucus, discharge of mucus, loose cough Rumex Crispus 6X HPUS runny nose, sneezing Silicea 12X HPUS nasal congestion HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses*
■ Helps temporarily relieve symptoms of common cold in children, including:
■ accumulation of mucus in chest, throat or nose
■ cough with mucus ■ runny nose ■ sneezing
■ nasal or chest congestionWarnings
Ask a doctor before use if you have
■ persistent or chronic cough such as 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 syringe provided. ■ Do not use dosing
syringe with other products. ■ On dosing syringe, mL = milliliter.Children under
6 monthsAsk a doctor before use. Children 6 months
to under 1 year2.5 mL up to 4 times per day
(every 6 hours).Children 1 year
to under 3 years5 mL up to 6 times per day
(every 4 hours). -
NIGHTTIME
Drug Facts
Active ingredients Purpose* Allium Cepa 6X HPUS runny nose with mucus, hacking cough, sore throat Bryonia Alba 6X HPUS stubborn mucus in throat, cough with mucus Chamomilla 3X HPUS occasional sleeplessness Coffea Cruda 3X HPUS occasional sleeplessness Euphrasia Offcinalis 6X HPUS cough with mucus in chest Hepar Sulph Calc 12X HPUS cough up mucus, mucus rattle with cough, stubborn mucus in chest Hydrastis 6X HPUS cough with mucus, dry/sore throat, occasional sleeplessness due to mucus in throat Natrum Muriaticum 6X HPUS accumulation of mucus in throat, cough up mucus Phosphorus 30X HPUS cough with mucus, chest congestion Pulsatilla 6X HPUS accumulation of mucus, discharge of mucus, loose cough Rumex Crispus 6X HPUS runny nose, sneezing Silicea 12X HPUS nasal congestion Sulphur 12X HPUS cough with thick mucus, chest congestion, nasal congestion "HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses*
■ Helps temporarily relieve symptoms of common cold in children at night, including:
■ accumulation of mucus in chest, throat or nose
■ cough with mucus ■ runny nose ■ sneezing
■ nasal or chest congestion ■ 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 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 syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter.
Children under
6 monthsAsk a doctor before use. Children 6 months
to under 1 year2.5 mL at bedtime and every 6 hours
during the night until relieved.Children 1 year
to under 3 years5 mL at bedtime and every 4 hours
during the night until relieved. - Drug Facts (continued)
- Questions?
- DAYTIME HOMEOPATHIC ACTIVE INGREDIENTS 10%
- NIGHTTIME HOMEOPATHIC ACTIVE INGREDIENTS 10%
- *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED .
- DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
- PURPOSE
-
Principal Display Panel
Hyland's
NATURALS™
•baby•
Mucus + Cold Relief*
COMBO PACK
NO SUGAR, PARABENS or DYES
DAYTIME
Mucus*
Congestion*
Runny Nose*
Sneezing*
Cough*
NIGHTTIME
Sleeplessness*
Mucus*
Congestion*
Runny Nose*
Sneezing*
Cough*
6+ MONTHS
DAYTIME - NO ALCOHOL
NIGHTTIME - LESS THAN 0.2% ALCOHOL
TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)
HOMEOPATHIC
-
INGREDIENTS AND APPEARANCE
BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME
calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3374 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3374-1 1 in 1 CARTON; Type 0: Not a Combination Product 11/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 118 mL Part 2 1 BOTTLE 118 mL Part 1 of 2 BABY MUCUS PLUS COLD RELIEF
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquidProduct Information Item Code (Source) NDC:54973-3284 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 RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 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 30 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) LICORICE (UNII: 61ZBX54883) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3284-1 118 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 05/13/2016 Part 2 of 2 BABY NIGHTTIME MUCUS PLUS COLD RELIEF
calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla liquidProduct Information Item Code (Source) NDC:54973-3371 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [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 30 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 3 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3371-2 118 mL in 1 BOTTLE; 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 11/01/2018 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3374) , pack(54973-3374) , label(54973-3374)