OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS (HPUS):
Aconitum napellus 4X
Bryonia alba 4X
Eucalyptus globulus 2X
Eupatorium perfoliatum 2X
Gelsemium sempervirens 4X
Ipecacuanha 3X
Phosphorus 6X
ACTIVE INGREDIENTS (HPUS):
Aconitum napellus 4X
Bryonia alba 4X
Eucalyptus globulus 2X
Eupatorium perfoliatum 2X
Gelsemium sempervirens 4X
Ipecacuanha 3X
Phosphorus 6X
INACTIVE INGREDIENT:
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Dosage and Administration:
Directions: Sublingual medication. Place tablet under tongue at least 15 minutes before and a half hour after eating, brushing teeth, or drinking anything except water.
Adults and children 12 years of age and older:
At first sign of cold or flu, take 1 tablet every hour or 2 or 3 tablets before going to sleep.
As symptoms subside, take 1 tablet every 2 to 3 hours.
Children 2 to 12:
Half of the adult dose.
Children under 2:
Consult a doctor.
Indication and Usage:
Uses: Temporarily relieves fever, chills, sneezing, stuffed-up nose, runny nose, coughing, sore throat, headache, minor aches and pains that may accompany colds or flu.
WARNINGS:
Consult a doctor if symptoms worsen, do not improve within 7 days, or new symptoms appear.
If fever lasts more than 3 days, or if sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, difficulty breathing, headache, rash, swelling, nausea, or vomiting, consult a doctor.
If cough persists for more than 7 days, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor.
A persistent cough may be a sign of a serious condition.
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Pregnancy or Breast Feeding:
If pregnant or breast-feeding, ask a healthcare professional before use.
Children:
Keep out of the reach of children.
Ask the Doctor:
Consult a doctor if symptoms worsen, do not improve within 7 days, or new symptoms appear.
If fever lasts more than 3 days, or if sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, difficulty breathing, headache, rash, swelling, nausea, or vomiting, consult a doctor.
If cough persists for more than 7 days, tends to recur, or is accompanied by a fever, rash or persistent headache, consult a doctor.
A persistent cough may be a sign of a serious condition.
Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
Overdosage:
In case of overdose, seek medical help or contact a Poison Control Center immediately.
Purpose:
Uses: Temporarily relieves fever, chills, sneezing, stuffed-up nose, runny nose, coughing, sore throat, headache, minor aches and pains that may accompany colds or flu.
Package Label and Principal Display:
21800490_03
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACONITUM NAPELLUS | ACTIVE INGREDIENT | U0NQ8555JD | 2 | |
| BRYONIA ALBA ROOT | ACTIVE INGREDIENT | T7J046YI2B | 2 | |
| EUCALYPTUS GLOBULUS LEAF | ACTIVE INGREDIENT | S546YLW6E6 | 2 | |
| EUPATORIUM PERFOLIATUM FLOWERING TOP | ACTIVE INGREDIENT | 1W0775VX6E | 2 | |
| GELSEMIUM SEMPERVIRENS ROOT | ACTIVE INGREDIENT | 639KR60Q1Q | 2 | |
| IPECAC | ACTIVE INGREDIENT | 62I3C8233L | 2 | |
| PHOSPHORUS | ACTIVE INGREDIENT | 27YLU75U4W | 2 | |
| ACONITUM NAPELLUS | ACTIVE MOIETY | U0NQ8555JD | 2 | |
| BRYONIA ALBA ROOT | ACTIVE MOIETY | T7J046YI2B | 2 | |
| EUCALYPTUS GLOBULUS LEAF | ACTIVE MOIETY | S546YLW6E6 | 2 | |
| EUPATORIUM PERFOLIATUM FLOWERING TOP | ACTIVE MOIETY | 1W0775VX6E | 2 | |
| GELSEMIUM SEMPERVIRENS ROOT | ACTIVE MOIETY | 639KR60Q1Q | 2 | |
| IPECAC | ACTIVE MOIETY | 62I3C8233L | 2 | |
| PHOSPHORUS | ACTIVE MOIETY | 27YLU75U4W | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53499-0339 | 53499-0339-1, 53499-0339-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACONITUM NAPELLUS | U0NQ8555JD | ACTIB |
| LACTOSE MONOHYDRATE | EWQ57Q8I5X | IACT |
| BRYONIA ALBA ROOT | T7J046YI2B | ACTIB |
| EUCALYPTUS GLOBULUS LEAF | S546YLW6E6 | ACTIB |
| EUPATORIUM PERFOLIATUM FLOWERING TOP | 1W0775VX6E | ACTIB |
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| IPECAC | 62I3C8233L | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY | 193.8 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IMPLANT / INTRAVITREAL | 1.66 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | PELLET / ORAL | 1140 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TROCHE / ORAL | 315 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER / VAGINAL | 430 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SOLUTION / ORAL | 1682 mg/15ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / SUBLINGUAL | 352 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / ORAL | 25 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | GRANULE, FOR SUSPENSION / ORAL | 512.5 mg/5ml | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / RECTAL | 20 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CONCENTRATE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / ORAL | 530 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / ORAL | 2500 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE / ORAL | 256.4 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SYSTEM / INTRAVITREAL | 0.02 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE / RESPIRATORY (INHALATION) | 44.4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, ORALLY DISINTEGRATING / ORAL | 1800 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, EXTENDED RELEASE / ORAL | 117 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, DELAYED RELEASE / ORAL | 160 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / BUCCAL | 296.7 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | POWDER, FOR SOLUTION / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 133 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SOLUTION / ORAL | 690 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | SUSPENSION / ORAL | 1600 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CAPSULE, COATED PELLETS / ORAL | 135.2 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAVENOUS | 203.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / INTRAVITREAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, SUGAR COATED / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET, CHEWABLE / ORAL | 1412 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE / ORAL | 29520 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 133 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | FILM, EXTENDED RELEASE / TRANSDERMAL | 675 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, COATED PELLETS / ORAL | 456 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SUPPOSITORY / VAGINAL | NA |
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 |
|---|---|---|---|---|---|---|
| 210cc887-bf3a-4deb-9b03-825225f23da1 | 9b6229bf-87d0-4004-a616-b172d758ea7f | 2017-03-22 | Warnings | 210cc887-bf3a-4deb-9b03-825225f23da1 9b6229bf-87d0-4004-a616-b172d758ea7f |
Adverse event summaries are temporarily unavailable. Other product information remains available.