■ Temporarily relieves symptoms of irritability or restlessness in children, including: ■ occasional sleeplessness ■ fussiness ■ agitation ■ restless sleep ■ unpredictable or irregular sleep ■ waking at night ■ crying ■ inconsolable behavior
■ Use as directed. Children under 6 months Ask a doctor before use. Children 6 months to under 1 year At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. Children 1 year to under 3 years At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.
www.hylands.comDrug Facts
| Active ingredients | Purpose |
|---|---|
| "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States. | |
| Chamomilla 6X HPUS | occasional sleeplessness, fussiness, and agitation |
| Coffea Cruda 6X HPUS | irritability |
| Ignatia Amara 30X HPUS
(less than 0.0000000000001% Alkaloids, calculated) | restless sleep |
| Lycopodium 30X HPUS | unpredictable, irregular sleep |
| Natrum Muriaticum 6X HPUS | crying, irritability |
| Platinum Metallicum 30X HPUS | causeless crying, waking at night |
| Pulsatilla 6X HPUS | cries easily, inconsolable |
| Sulphur 12X HPUS | crying, restlessness, irritability |
■ Temporarily relieves symptoms of irritability or restlessness in children, including:
■ occasional sleeplessness ■ fussiness ■ agitation
■ restless sleep ■ unpredictable or irregular sleep ■ waking at night
■ crying ■ inconsolable behavior
Stop use and ask a doctor if: ■ symptoms persist for more than 72 hours or worsen.
■ symptoms are accompanied by a fever.
Keep out of reach of children.
■ Use as directed.
| Children under 6 months | Ask a doctor before use. |
| Children 6 months
to under 1 year | At onset of symptoms, dissolve 2 tablets on tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. |
| Children 1 year
to under 3 years | At onset of symptoms, dissolve 3 tablets on tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved. |
Acacia Gum, Lactose.
www.hylands.com or (800) 624-9659
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE,
NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
■ Temporarily relieves symptoms of irritability or restlessness in children, including:
■ occasional sleeplessness ■ fussiness ■ agitation
■ restless sleep ■ unpredictable or irregular sleep ■ waking at night
■ crying ■ inconsolable behavior
■ Use as directed.
| Children under 6 months | Ask a doctor before use. |
| Children 6 months
to under 1 year | At onset of symptoms, dissolve 2 tablets on tongue
every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. |
| Children 1 year
to under 3 years | At onset of symptoms, dissolve 3 tablets on tongue
every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved. |
Hyland's
Naturals™
•baby•
Calming
Tablets*
NO ARTIFICIAL FLAVORS,
DYES or PARABENS
Sleeplessness
Fussiness
Irritability
6+ MONTHS
125
QUICK-DISSOLVING TABLETS
HOMEOPATHIC
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54973-3308-1 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a920-d8a0-e053-dadaa90a6e4e | Hyland's Naturals Baby Calming |
| 54973-3308-2 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-a920-d8a0-e053-dadaa90a6e4e | Hyland's Naturals Baby Calming |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54973-3308-1 | BABY CALMING | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 54973-3308-1 | BABY CALMING | 125 in 1 BOTTLE, PLASTIC | TABLET | 125 | 5 | |
| 54973-3308-2 | BABY CALMING | 6 in 1 PACKET | TABLET | 6 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54973-3308 | BABY CALMING (MATRICARIA RECUTITA, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, PLATINUM, ANEMONE PULSATILLA, AND SULFUR) TABLET [HYLAND'S] | 5 | Legacy NDC, 3 package rows | 20211221_8f20251b-111b-4b7b-8098-4371d04004bd.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54973-3308 | 54973-3308-1, 54973-3308-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACACIA | 5C5403N26O | IACT |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| MATRICARIA RECUTITA | G0R4UBI2ZZ | ACTIB |
| ARABICA COFFEE BEAN | 3SW678MX72 | ACTIB |
| STRYCHNOS IGNATII SEED | 1NM3M2487K | ACTIB |
| LYCOPODIUM CLAVATUM SPORE | C88X29Y479 | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| PLATINUM | 49DFR088MY | ACTIB |
| ANEMONE PULSATILLA | I76KB35JEV | ACTIB |
| SULFUR | 70FD1KFU70 | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d39e88d5-38bc-2f7a-e053-2995a90a9eb2 | 8f20251b-111b-4b7b-8098-4371d04004bd | 2021-12-20 | Warnings | d39e88d5-38bc-2f7a-e053-2995a90a9eb2 8f20251b-111b-4b7b-8098-4371d04004bd |
Adverse event summaries are temporarily unavailable. Other product information remains available.