| NDC | 52053-0002-1, 52053-0002-2 |
| Set ID | 114c133a-a312-4198-93e1-21f6466ce197 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | PharmaCare US, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number |
- ACTIVE INGREDIENTS:
- INDICATIONS:
-
WARNINGS:
Sore Throat Warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a 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 last for more than three days - Respiratory symptoms persist for more than seven days.
If pregnant or breast feeding: ask a health care 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 bottle 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: Take 1 serving (10 ml) at the onset of symptoms.
-Repeat every three hours until symptoms are gone.
-Children under 4 years of age: Consult a doctor before use.
-
INDICATIONS:
Samucol Cold & Flu Night-Time Relief:
- Safe for the whole family*
- No known drug interactions
- No known side effects
- Pleasant berry taste
- Fast temporary relief from cold & flu symptoms
- Provides a restful night's sleep
- With natural elderberry & zinc
- Unique homeopathic formulation
- Great tasting syrup
- Soothing to the throat
- Non-habit forming
*Children under 4: Consult a doctor before use.
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE DISPLAY LABEL:
-
INGREDIENTS AND APPEARANCE
SAMBUCOL COLD AND FLU NIGHT TIME SYRUP
byronia, chamomilla, gelsemium sempervirens, passiflora incarnata, sambucus nigra, silicea, sulphur, zincum gluconicum, water liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52053-0002 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 6 [hp_X] in 1 mL SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 4 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E) FRUCTOSE (UNII: 6YSS42VSEV) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52053-0002-2 1 in 1 CARTON 09/06/2013 02/19/2022 1 NDC:52053-0002-1 120 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 drug other 09/06/2013 02/19/2022 Labeler - PharmaCare US, Inc. (026889965) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(52053-0002) , api manufacture(52053-0002) , label(52053-0002) , pack(52053-0002)
