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NDC 52053-0004-01 Sambucol Cold and Flu Relief 6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg Details
Sambucol Cold and Flu Relief 6; 6; 3; 12; 2 [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg
Sambucol Cold and Flu Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by PharmaCare US, Inc.. The primary component is BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; ZINC GLUCONATE.
Product Information
| NDC | 52053-0004 |
|---|---|
| Product ID | 52053-0004_4965b936-5b69-4de6-a5c5-b127c922423a |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Sambucol Cold and Flu Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bryonia, Gelsemium Sempervirens, Sabucus Nigra, Sulphur, Zincum Gluconicum |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 6; 6; 3; 12; 2 |
| Active Ingredient Units | [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg; [hp_X]/mg |
| Substance Name | BRYONIA ALBA ROOT; GELSEMIUM SEMPERVIRENS ROOT; SAMBUCUS NIGRA FLOWERING TOP; SULFUR; ZINC GLUCONATE |
| Labeler Name | PharmaCare US, Inc. |
| Pharmaceutical Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED HOMEOPATHIC |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 52053-0004-01 (52053000401)
| NDC Package Code | 52053-0004-1 |
|---|---|
| Billing NDC | 52053000401 |
| Package | 4 BLISTER PACK in 1 CARTON (52053-0004-1) / 4500 mg in 1 BLISTER PACK (52053-0004-2) |
| Marketing Start Date | 2021-10-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7dace656-ee97-4931-869f-8c8022757abb Details
ACTIVE INGREDIENTS:
INDICATIONS:
•Temporarily relieves cold & flu symptoms.
• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and
headache.
• Also temporarily relieves body aches associated with the flu.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
WARNINGS:
Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician. Stop use and ask a doctor if
• Symptoms worsen. • Any new symptoms appear.
• Fever lasts for more than three days. • Respiratory symptoms persist for more than seven days.
If pregnant or breast feeding, ask a health professional before using.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• Do not use if blister seal is broken.
KEEP OUT OF REACH OF CHILDREN:
DIRECTIONS:
For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside.
Adults and children 4 years of age and older. Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.
INDICATIONS:
•Temporarily relieves cold & flu symptoms.
• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and
headache.
• Also temporarily relieves body aches associated with the flu.
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
INACTIVE INGREDIENTS:
QUESTIONS:
PACKAGE LABEL DISPLAY:
INGREDIENTS AND APPEARANCE
| SAMBUCOL COLD AND FLU RELIEF
bryonia, gelsemium sempervirens, sabucus nigra, sulphur, zincum gluconicum tablet |
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| Labeler - PharmaCare US, Inc. (026889965) |
| Registrant - Apotheca Company (844330915) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Apotheca Company | 844330915 | manufacture(52053-0004) , api manufacture(52053-0004) , label(52053-0004) , pack(52053-0004) | |