| NDC | 54973-3371-1, 54973-3371-2, 54973-3371-3 |
| Set ID | 736b2487-e81d-d172-e053-2a91aa0ab0cf |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Hyland's |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
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Drug Facts
Active ingredients
Allium Cepa 6X HPUS
Bryonia Alba 6X HPUS
Chamomilla 3X HPUS
Coffea Cruda 3X HPUS
Euphrasia Officinalis 6X HPUS
Hepar Sulph Calc 12X HPUS
Hydrastis 6X HPUS
Natrum Muriaticum 6X HPUS
Phosphorus 30X HPUS
Pulsatilla 6X HPUS
Rumex Crispus 6X HPUS
Silicea 12X HPUS
Sulphur 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic
Pharmacopoeia of the United States.
Purpose
Allium Cepa 6X HPUS..........runny nose with mucus, hacking cough, sore throat
Bryonia Alba 6X HPUS...stubborn mucus in throat, cough with yellowish mucus
Chamomilla 3X HPUS..................irritability, fussiness, occasional sleeplessness
Coffea Cruda 3X HPUS.............................occasional sleeplessness, restlessness
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
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 expectoration of yellow mucus,chest congestion
Pulsatilla 6X HPUS.............accumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUS...............................................runny nose and sneezing
Silicea 12X HPUS.......................................................................nasal congestion
Sulphur 12X HPUS...cough with thick mucus, chest congestion, nasal congestion
Uses
Temporarily relieves symptoms of colds, including accumulation of
mucus in chest, throat and nose, cough with mucus, runny nose, sneezing,
nasal congestion and irritability, fussiness and occasional sleeplessness.
Warnings
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 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.
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Drug Facts (continued)
Directions
- Measure only with the dosing syringe provided
- Do not use dosing syringe with other products
- On dosing syringe, mL = milliliter, tsp = teaspoon
Children under
6 months of age
consult a licensed health care
professional before using this product
Children 6 months to
under 1 year of age
2.5 mL or ½ teaspoon at
bedtime and every 6 hours
during the night or as necessary.
Children 1 to 3
years of age
5 mL or 1 teaspoon at bedtime
and every 4 hours during the
night or as necessary.
- Inactive ingredients
- Questions or comments?
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Principal Display Panel - 148 mL Bottle Label Carton
25% FREE
BONUS PACK
NDC 54973-3371-1
HOMEOPATHIC
Ages
6 months+
NATURAL
RELIEF
SINCE 1903
Hyland's
baby
Nighttime
Mucus +
Cold Relief*
LOOSENS MUCUS,
RELIEF OF
CONGESTION,
AND OCCASIONAL
SLEEPLESSNESS
DUE TO COLDS
No Artificial Flavors,
Dyes or Parabens
LESS THAN 0.2% ALCOHOL
4 + 1 = 5 FL. O Z. (148 mL)
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INGREDIENTS AND APPEARANCE
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 Product Type HUMAN OTC DRUG 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 PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [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 GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [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 MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 3 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 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 SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3371-1 1 in 1 CARTON 11/01/2018 1 148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:54973-3371-2 1 in 1 CARTON 11/01/2018 2 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 3 NDC:54973-3371-3 2.5 mL in 1 PACKET; Type 0: Not a Combination Product 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 (028570695) Establishment Name Address ID/FEI Business Operations Nexgen Pharma, Inc. 079424083 manufacture(54973-3371) , pack(54973-3371) , label(54973-3371) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 876754375 manufacture(54973-3371) , pack(54973-3371) , label(54973-3371)