NDC 45014-137 Childrens Accudial Pain Reliever/ Fever Reducer
Product Information
What is NDC 45014-137?
The NDC code 45014-137 is assigned by the FDA to the product Childrens Accudial Pain Reliever/ Fever Reducer which is product labeled by Accudial Pharmaceutical, Inc.. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 45014-137-04 118 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Childrens Accudial Pain Reliever/ Fever Reducer?
This product is used as Pain reliever/fever reducer. Temporarily relieves minor aches and pains due to:the common coldfluheadachesore throattoothacheTemporarily reduces fever
Product Characteristics
Color(s) | RED (C48326) |
Flavor(s) | BUBBLE GUM (C73368) |
Product Details
Childrens Accudial Pain Reliever/ Fever Reducer Active Ingredients UNII Codes
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 307668 - acetaminophen 160 MG in 5 mL Oral Suspension
- RxCUI: 307668 - acetaminophen 32 MG/ML Oral Suspension
- RxCUI: 307668 - acetaminophen 160 MG per 5 ML Oral Suspension
- RxCUI: 307668 - acetaminophen 320 MG per 10 ML Oral Suspension
- RxCUI: 307668 - acetaminophen 650 MG per 20.3 ML Oral Suspension
Childrens Accudial Pain Reliever/ Fever Reducer Inactive Ingredients UNII Codes
- CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
- CORN SYRUP (UNII: 9G5L16BK6N)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- D&C RED NO. 33 (UNII: 9DBA0SBB0L)
- GLYCERIN (UNII: PDC6A3C0OX)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- WATER (UNII: 059QF0KO0R)
- SODIUM BENZOATE (UNII: OJ245FE5EU)
- SUCRALOSE (UNII: 96K6UQ3ZD4)
- SORBITOL (UNII: 506T60A25R)
- XANTHAN GUM (UNII: TTV12P4NEE)
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Patient Education
Acetaminophen
Acetaminophen is pronounced as (a set a mee' noe fen)
Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
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Childrens Accudial Pain Reliever/ Fever Reducer Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- OTHER
- ACTIVE INGREDIENT (IN EACH 5 ML = 1 TEASPOON)
- PURPOSE
- USES
- LIVER WARNING
- SORE THROAT WARNING
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 120 ML BOTTLE CARTON
Other
Drug Facts
DISTRIBUTED BY ACCUDIAL PHARMACEUTICAL, INC.
Palm Beach Gardens, FL 33408
Active Ingredient (In Each 5 Ml = 1 Teaspoon)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
Temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Temporarily reduces fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount.
- with other drugs containing acetaminophen.
Sore Throat Warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Otc - Do Not Use
Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
- If your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Otc - Ask Doctor
Ask a doctor before use if your child has liver disease.
Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Otc - When Using
When using this product: Do not use more than directed.
Otc - Stop Use
Stop use and ask a doctor if:
- Pain gets worse or lasts more than 5 days.
- Fever gets worse or lasts more than 3 days.
- New symptoms occur.
- Redness or swelling is present.
These could be signs of a serious condition.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.
Directions
This product does not contain directions or complete warnings for adult use.
- shake well before using
- if needed, repeat dose every 4 hours
- do not use more than 5 times in 24 hours
- when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.
when weight is unknown: use the age chart on the rotating label. - use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device
Age (yr) | Dose (mL or tsp) |
---|---|
tsp. = teaspoon | |
mL = milliliter | |
under 6 mos. | ask a doctor |
6 mos. to under 2 | 2.5 mL or ½ tsp. |
2 to under 4 | 5 mL or 1 tsp. |
4 to under 6 | 7.5 mL or 1½ tsp. |
6 to under 9 | 10 mL or 2 tsp. |
9 to under 11 | 12.5 mL or 2½ tsp. |
11 to under 12 | 15 mL or 3 tsp. |
or as directed by a doctor |
Ask a doctor before use if your child is under 6 mos. or 12 lbs. OR over 12 yrs. or 95 lbs.
Other Information
- each teaspoon contains: sodium 2 mg
- store between 20°-25°C (68°-77°F)
- tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
Inactive Ingredients
artificial flavor, citric acid anhydrous, corn syrup, D&C red #33, FD&C red #40, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions?
877-434-2036
Principal Display Panel - 120 Ml Bottle Carton
Children's
ACCUDIAL®
Acetaminophen
Oral Suspension
Pain Reliever / Fever Reducer
For ages 6 mos. to
under 12 yrs. or 12-95 lbs.
Alcohol Free • Aspirin Free • Ibuprofen Free
Compares to the active
ingredient in Children's
Tylenol® Oral Suspension.
ROTATING
LABEL FOR
WEIGHT-BASED
DOSING
Bubblegum
Flavor
4 FL.OZ. (120 mL)
80 mg per 1/2 teaspoon
(160 mg per 5 mL)
NDC 45014-137-04
* Please review the disclaimer below.