Label: JUNIOR STRENGTH PAIN RELIEF - acetaminophen tablet
- NDC Code(s): 66007-145-01, 66007-145-02
- Packager: Capricorn Pharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active Ingredient(in each tablet)
Pain Reliever/Fever ReducerClose
temporarily relieves minor aches and pains due to:
■ the common cold
■ temporarily reduces feverClose
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
■ more than 5 doses in 24 hours, which is maximum daily amount
■ with other drugs containing acetaminophen
Do not use
■ with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Stop use and ask doctor if
■ new symptoms occur
■ redness or swelling is present
■ pain gets worse or lasts for more than 5 days
■ fever gets worse or lasts for more than 3 days
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 even if you do not notice any signs or symptoms.
This product does not contain directions or complete warnings for adult use.
Do not exceed recommended dose (see overdose warning)
■ find right dose on chart below. If possible, use weight to dose; otherwise, use age
■ dissolve in mouth or chew before swallowing
■ if needed, repeat dose every 4 hours
■ do not use more than 5 times in 24 hours
96 and over
Ask a doctor
- Other Information
■ Do not use if blister unit is broken or shows signs of tampering.Close
■ Store between 20-25ºC (68-77ºF). Avoid high humidity. Protect from light.
■ See end panel for lot number and expiration date.
- Inactive Ingredient
Crospovidone, D & C red # 7, D & C red # 30, ethylcellulose, FD & C blue # 1, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, silicon dioxide, sodium lauryl sulfate, sodium starch glycolate, sucralose, talc, triethyl citrateClose
- Principal Display Panel
ORIGINAL DEVELOPERS AND MANUFACTURERS
Compare to the active ingredient of Junior Tylenol Meltaways
ACETAMINOPHEN - 160mg each
For Children Ages 6-11
See new warnings information
* Fever Reducer
* Pain Reliever
* Contains no Aspirin
* Melts in your mouth
24 Fast Dissolving Tablets
- INGREDIENTS AND APPEARANCE
JUNIOR STRENGTH PAIN RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66007-145 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg Product Characteristics Color purple (light purple/violet) Score 2 pieces Shape ROUND (Round Lozenge) Size 14mm Flavor GRAPE Imprint Code CP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66007-145-02 4 in 1 CARTON 1 NDC:66007-145-01 6 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/26/2010 Labeler - Capricorn Pharma Inc. (041704524) Registrant - Capricorn Pharma Inc. (041704524) Establishment Name Address ID/FEI Business Operations Capricorn Pharma Inc. 041704524 manufacture