FDA Label for Infants Pain Relief Dye-free
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
- PDP
Infants Pain Relief Dye-free Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. 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
- relieves minor aches and pains due to:
- the common cold
- sore throat
- flu
- toothache
- headache
Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:
- more than 5 doses in 24 hours, which is maximum daily amount
- with other drugs containing acetaminophen
- Sore throat warning: if sore throat is severe, persists for more than 2 days, or 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). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- 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
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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 right away. 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 dose
do not give more than directed (see overdose warning)
shake well before use
- use only enclosed dosing syringe
- find right dose on chart below
- remove cap and insert syringe, invert the bottle and draw the liquid to the prescripbed level.
- dispense liquid slowly into childs mouth towards inner cheek
- repeat dose every 4 hours if needed
- do not give more than 5 times in 24 hours
- replace the cap tightly to maintain child resistance
- return dispenser to the box after thorough cleaning
| Weight (lb) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
* or as directed by a doctor
Other Information
- store between 20-25oC(68-77oF)
Inactive Ingredients
citric acid anhydrous, butyl paraben, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum
Pdp
*Compare to the active ingredient in Childrens TYLENOL®Suspension
Infants Oral Suspension Pain relief
ACETAMINOPHEN 160 mg per 5 mL
PAIN RELIEVER-FEVER REDUCER
Alcohol Free
Aspirin & Ibuprofen Free
For Ages 2-3 Years
Dye-Free
Cherry Flavor
2 FL OZ (60 mL) 160 mg per 5 mL
* Please review the disclaimer below.