ERGOCALCIFEROL liquid

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Ergocalciferol (UNII: VS041H42XC) (Ergocalciferol - UNII:VS041H42XC)

Tilgjengelig fra:

Virtus Pharmaceuticals

INN (International Name):

Ergocalciferol

Sammensetning:

Ergocalciferol 0.2 mg in 1 mL

Administreringsrute:

ORAL

Indikasjoner:

Contraindicated in people with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Produkt oppsummering:

Each 60 mL polycarbonate screw top bottle contains 60 mL ergocalciferol in a propylene glycol base (0.2 mg ergocalciferol per mL). Store at 20˚-25˚ C (68˚-77˚F); excursion permitted between 15˚-30˚ C (59˚-86˚ F).

Autorisasjon status:

Dietary Supplement

Informasjon til brukeren

ERGOCALCIFEROL - LIQUID
VIRTUS PHARMACEUTICALS * DIETARY SUPPLEMENT
INDEX * 1. STATEMENT OF IDENTITY * 2. SUPPLEMENT FACTS * 3. DESCRIPTION * 4. DIRECTIONS FOR USE * 5. CONTRAINDICATIONS * 6. WARNING * 7. CAUTION * 8. SIDE EFFECTS * 9. HOW SUPPLIED * 10. HEALTH CLAIM * 11. SAFE HANDLING WARNING * 12. MANUFACTURED FOR * 13. PRINCIPAL DISPLAY PANEL - ML BOTTLE CARTON *
1. STATEMENT OF IDENTITY
69543-234-60
Vitamin D Supplement Drops
8000 lU (0.2mg) Ergocalciferol per mL *
2. SUPPLEMENT FACTS Supplement Facts Serving Size: 400 IU
Serving Per Container: 1200 Amount Per Serving % Daily Value Vitamin D (ergocalciferol) 400 IU 100%
Other Ingredients: Propylene Glycol
The US RDA for Vitamin D is 400 IU for children and adults. *
3. DESCRIPTION
Each mL contains 8000 IU (0.2 mg) of ergocalciferol (Vitamin D2)
dissolved in propylene glycol. *
4. DIRECTIONS FOR USE
400 IU daily to be taken orally using the supplied pre-measured
syringe. Submerge the tip of the syringe into the liquid, pull plunger
back to bring the liquid to the 400 IU mark, and dispense into mouth.
DO NOT FILL SYRINGE ENTIRELY. *
5. CONTRAINDICATIONS
Contraindicated in people with hypercalcemia, malabsorption syndrome,
abnormal sensitivity to the toxic effects of vitamin D, and
hypervitaminosis D. *
6. WARNING
In case of accidental overdose contact a doctor or poison control
center immediately.
Hypersensitivity to vitamin D may be a causative factor in infants
with idiopathic hypercalcemia. In these children, vitamin D must be
strictly restricted. *
7. CAUTION
Adequate dietary calcium is necessary for response to vitamin D
therapy. *
8. SIDE EFFECTS
Metabolic side effects include hypercalcemia.
You may report serious side effects by calling Virtus at
1-888-848-3593 or FDA at 1-800-FDA-1088 *
9. HOW SUPPLIED
Each 60 mL polycarbonate screw top bottle contains 60 mL
ergocalciferol in a propylene glycol base (0.2 mg ergocalciferol per
mL).
Store at 20˚-25˚ C (68˚-77˚F); excursion permitted between
15˚-30˚ C (59˚-86˚ F). *
10. HEALTH CLAIM
Adequate intak

Preparatomtale

ERGOCALCIFEROL- ERGOCALCIFEROL LIQUID
VIRTUS PHARMACEUTICALS
----------
ERGOCALCIFEROL
ORAL SOLUTION, USP
69543-234-60
Vitamin D Supplement Drops
8000 lU (0.2mg) Ergocalciferol per mL
SUPPLEMENT FACTS
Serving Size: 400 IU
Serving Per Container: 1200
AMOUNT PER
SERVING
% DAILY VALUE
VITAMIN D (ergocalciferol)
400 IU
100%
Other Ingredients: Propylene Glycol
The US RDA for Vitamin D is 400 IU for children and adults.
DES CRIPTION
Each mL contains 8000 IU (0.2 mg) of ergocalciferol (Vitamin D )
dissolved in propylene glycol.
DIRECTIONS FOR USE
400 IU daily to be taken orally using the supplied pre-measured
syringe. Submerge the tip of the
syringe into the liquid, pull plunger back to bring the liquid to the
400 IU mark, and dispense into mouth.
DO NOT FILL SYRINGE ENTIRELY.
CONTRAINDICATIONS
Contraindicated in people with hypercalcemia, malabsorption syndrome,
abnormal sensitivity to the
toxic effects of vitamin D, and hypervitaminosis D.
WARNING
In case of accidental overdose contact a doctor or poison control
center immediately.
Hypersensitivity to vitamin D may be a causative factor in infants
with idiopathic hypercalcemia. In
these children, vitamin D must be strictly restricted.
CAUTION
Adequate dietary calcium is necessary for response to vitamin D
therapy.
SIDE EFFECTS
Metabolic side effects include hypercalcemia.
You may report serious side effects by calling Virtus at
1-888-848-3593 or FDA at 1-800-FDA-1088
2
HOW SUPPLIED
Each 60 mL polycarbonate screw top bottle contains 60 mL
ergocalciferol in a propylene glycol base
(0.2 mg ergocalciferol per mL).
Store at 20˚-25˚ C (68˚-77˚F); excursion permitted between
15˚-30˚ C (59˚-86˚ F).
Adequate intake (AI) (minimum daily intake) of vitamin D is needed to
support calcium metabolism and
bone health, particularly in the young and old.
1
KEEP THIS AND ALL
MEDICATIONS OUT OF THE
REACH OF CHILDREN.
TAMPER RESISTANT FEATURE:
Do NOT use if imprinted seal on cap is
broken or missing.
MANUFACTURED FOR:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
1-888-848-3593
Made