FDA Label for Pain And Fever Relief Infants
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 5 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOUR CHILD HAS
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOUR CHILD IS
- WHEN USING THIS PRODUCT,
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Pain And Fever Relief Infants Product Label
The following document was submitted to the FDA by the labeler of this product Dolgencorp, Inc. (dollar General & Rexall). 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.
Active Ingredient (In Each 5 Ml)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily reduces fever
- temporarily relieves minor aches and pains due to:
- flu
- the common cold
- headache
- sore throat
- toothache
Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:
- skin reddening
- blisters
- rash
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
If a skin reaction occurs, stop use and seek medical help right away
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
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.
Do Not Use
- with any other drug containing acetaminophen (prescription or non prescription). 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.
Ask 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
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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.
- do not take more than the recommended dose (see overdose warning)
- shake well before using
- mL= milliliter
- only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child
- remove cap, insert syringe into hole at top of bottle until it snaps into place and turn upside down
- pull back syringe until filled to be prescribed level. If you pass the prescribed level, invert assembly to right side up on flat surface and simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek)
- If needed, repeat dose every 4 hours while syptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- replace cap tightly to maintain child resistance
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age
Weight (lb) | Age (yr) | Dose (mL) |
under 24 | under 2 years | ask a doctor |
24-35 | 2-3 years | 5 mL |
Other Information
- store between 20-25°C (68-77°F)
- do not refrigerate.
- see bottom panel for lot number and expiration date
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, FD&c red #40, flavors, glycerin, high fructose corn syrup, microcrystalline celllulose, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum
Questions Or Comments?
Call 1-888-309-9030
Principal Display Panel
Compare to active ingredient of Infants' Tylenol® Oral Suspension**
For Ages 2 to 3 Years
Infants'
Pain & Fever Relief
Acetaminophen
160 mg per 5 mL
Oral suspension
Pain Reliever / Fever Reducer
- Alcohol free
- Aspirin free
- Ibuprofen free
Enhanced dosing system reduces the chance of accidental ingestion and overdose
Use only enclosed syringe
FL OZ (mL)
CHERRY FLAVOR
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Infants' Tylenol® Oral Suspension.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED SAFETY SEAL AROUND THE BOTTLE IS BROKEN OR MISSING.
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
Package Label
DOLLAR GENERAL HEALTH Pain & Fever Relief Cherry Flavor
* Please review the disclaimer below.