FDA Label for Childrens Pain And Fever
View Indications, Usage & Precautions
- DRUG FACTSACTIVE INGREDIENT(IN EACH 5 ML = 1 TEASPOONFUL)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- WHEN USING THIS PRODUCT DO NOT EXCEED RECOMMENDED DOSE.
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIANTS
- QUESTIONS
- CHILDREN'S PAIN & 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
Uses
temporarily
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Warnings
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 acteaminophen
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include
If a skin reaction occurs, stopuse and seek medical help right away.
Sore throat warning: If a sore throat is severe, persiss for more than 2 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 to any of the inactive ingredients in this product
Ask A Doctor 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 warnings)
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.
Keep Out Of Reach Of Children.
Keep out of reach of children.
Overdose Warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for 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 = millititer; tsp = teaspoonful
- 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 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
* or as directed by a doctor
Attention: use only enclosed dosing cup specfically designed for use with this product. Do not use any other dosing dvice
Other Information
- eash 5mL (1 tsp) contains sodium 3mg
- store between 20-25
Inactive Ingrediants
anhydrous citric acid, butylparaben, D&C Red # 33, FD&C (red), flavor, glycerin, flavor, high frucotose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions
Call weekays from 9:30 AM to 4:30 PM
Children's Pain & Fever Product Label
DISCOUNT
drug mart
FOOD FAIR
COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL® ORAL SUSPENSION
Fever Reducer / Pain Reliever
Children's Pain & Fever
Acetaminophen Oral Suspension
- Alcohol-Free
- Ibuprofen Free
- Aspirin Free
For Ages 2 to 11
GRAPE FLAVOR
4 FL OZ (118 mL)
160 mg per 5 mmL
* This product is not manufactures or distributed by McNeil Consumer Healthcare, distribbutor of Children's Tylenol® Oral Suspension.
BX-053
SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256
* Please review the disclaimer below.