![PAIN RELIEF INFANTS (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]](https://medic.hrt.org//dailymed/images/111931c9-b2ba-49c1-b2a6-bb978d85822e/infants-acetaminophen-grape-liquid-delisted-1.jpg)
| NDC | 63868-836-60 |
| Set ID | 111931c9-b2ba-49c1-b2a6-bb978d85822e |
| Category | HUMAN OTC DRUG LABEL |
| Packager | QUALITY CHOICE (Chain Drug Marketing Association) |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredient (in each 5 mL)
- Purpose
- Uses
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Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddenings
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetamnophen. 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
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 right away. (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.
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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
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age
- only use the enclosd syringe.
Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
- remove cap and insert syringe into hole at top of bottle and turn upside down.
- pull back syringe until filled to the 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 symptoms last.
- do not use 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
Weight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL
*or as directed by a doctor
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
**Compare to active ingredient in Infanus' Tylenol® Oral Suspension
Infants' Pain Relief
Oral Suspension
Acetaminophen 160mg per 5 mL
Pain Reliever & Fever Reducer
Alcohol free
Aspirin free
Ibuprofen free
Ages 2-3 years
FL OZ (mL)
Grape flavor
Use Only Enclosed Syringe
**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 C.D.M.A., Inc.©
43157 W.Nine Mile
Novi, MI 48376-0995
- Package Label
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INGREDIENTS AND APPEARANCE
PAIN RELIEF INFANTS
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-836 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLPARABEN (UNII: 3QPI1U3FV8) D&C RED NO. 33 (UNII: 9DBA0SBB0L) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-836-60 1 in 1 BOX 05/31/2015 02/23/2024 1 59 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/31/2015 02/23/2024 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
