Drug Facts
Drug Labeling and Warnings
Drug Details [pdf]
INFANTS PAIN AND FEVER- acetaminophen suspension
Preferred Pharmaceuticals Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Drug Facts
Uses
- temporarily reduces fever
-
temporarily 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 maximum daily amount
- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away
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.
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 directed (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 and turn upside down
- pull back syringe until filled to be prescribed level. If you pass the prescribed level, 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 (year) |
Dose (mL)* |
|
under 24 |
under 2 |
ask a doctor |
|
24-35 |
2-3 |
5 mL |
*or as directed by a doctor
Other information
- store between 20-25ºC (68-77ºF)
- do not refrigerate.
- see bottom panel for lot number and expiration date
Inactive ingredients
acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purfied water, sodium benzoate, sorbitol, xanthan gum
Principal Display Panel
ASPIRIN & ALCOHOL FREE
**COMPARE TO THE ACTIVE INGREDIENT IN INFANTS' TYLENOL® ORAL SUSPENSION
RELIEVES INFANTS'
Pain and Fever
Acetaminophen 160 mg per 5 mL Oral suspension
Pain reliever / Fever reducer
- Alcohol free
- Aspirin free
- ibuprofen free
For ages 2-3 years
Cherry flavor
Use only enclosed syringe
FL OZ (mL)
**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 IF PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.
Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Relabeled By: Preferred Pharmaceuticals Inc.
| INFANTS PAIN AND FEVER
acetaminophen suspension |
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| Labeler - Preferred Pharmaceuticals Inc. (791119022) |
| Registrant - Preferred Pharmaceuticals Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals Inc. | 791119022 | RELABEL(68788-7096) | |