FDA Label for Childrens Pain And Fever
View Indications, Usage & Precautions
- DRUG FACTSACTIVE INGREDIENT(IN EACH 5 ML = 1 TEASPOONFUL)
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN.
- USES
- WARNINGS
- DO NOT USE
- ASL A DOCTOR BEFORE USE IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSE (SEE OVERDOSE WARNING)STOP USE AND ASK A DOCTOR IF
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- DISCOUNT DRUG MART FOOD FAIR CHILDREN'S PAIN AND FEVER PRODUCT LABEL
Childrens Pain And Fever Product Label
The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Factsactive Ingredient(In Each 5 Ml = 1 Teaspoonful)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Keep Out Of Reach Of Children.
Keep out of reach of children.
Uses
temporarily
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Warnings
DO NOT USE IF PRINTED NECK BRAND IS BROKEN OR MISSING
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 maxium daily amount
- with other drugs containing acetaminophen
Sore throat warning
If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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.
Asl A Doctor Before Use If Your Child Has
liver disease
Ask A Doctor Or Pharmacist Before Use If Your Child Is
taking the blood thinning drug warfarin.
When Using This Product Do Not Exceed Recommended Dose (See Overdose Warning)Stop Use And Ask A Doctor If
- pain gets worseor 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 can liver damage. . In case of overdose, get medical help, or contact a Poison Control Center right away.(1-800-22212120.) Quick medical attention is critical for adults as well as children 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
- mL = milliter; tsp = teaspoon
- find right dose on chart below. If possible, use weight to dose; otherwise , use age.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor.
Weight (lb) | Age (yr) | Dose (mL or tsp)* |
under 24 | under 2 years | ask a doctor |
24 - 35 | 2 - 3 years | 5 mL (1 tsp) |
36 - 47 | 4 - 5 years | 7.5 mL (1 1/2 tsp) |
48 - 59 | 6 - 8 years | 10 mL (2 tsp) |
60 - 71 | 9 - 10 years | 12.5 mL ( 2 1/2 tsp) |
72 - 95 | 11 years | 15 mL (3 tsp) |
* or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other Information
- each 5 mL (1 tsp) contains: sodium 3 mg
- store between 20°-25°C (68°-77°F)
- do not refrigerate
Inactive Ingredients
anhydrous citric acid, butylparaben, FD and C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions?
Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
Discount Drug Mart Food Fair Children's Pain And Fever Product Label
COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL® ORAL SUSPENSION*
DISCOUNT
drug mart
FOOD FAIR
Fever Reducer/ Pain Reliever
Children's Pain and Fever
Acetaminophen Oral Suspension
- Alcohol-Free
- Ibuprofen Free
- Asprin Free
For ages 2 to 11
CHERRY FLAVOR
4 FL OZ (118 mL)
* This product is not manufactured or distributed by McNeil Consumer Healthcare, distributer of Children's Tylenol® Oral Suspension.
BX-043
SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION , NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256
* Please review the disclaimer below.