Label: ACETAMINOPHEN JUNIOR STRENGTH- acetaminophen tablet, chewable
- NDC Code(s): 41163-450-08
- Packager: SUPERVALU INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated November 29, 2017
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- Active ingredient (in each tablet)
Acetaminophen 160 mgClose
Pain reliever/fever reducerClose
- temporarily relieves minor aches and pains due to:
- the common cold
- sore throat
- temporarily reduces fever
- temporarily relieves minor aches and pains due to:
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
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 nonprescription). 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
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
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.
- do not give more than directed (see overdose warning)
- this product does not contain directions or complete warnings for adult use
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- chew before swallowing: this product will soften in mouth for ease of chewing
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
Weight (lb) Age (yr) Dose (tablets) * Under 48 Under 6 Ask a doctor 48-59 6-8 2 60-71 9-10 2 1/2 72-95 11 3
*or as directed by a doctorClose
- Other information
- store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- see end flap for expiration date and lot number
- avoid high humidity
- Inactive ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucraloseClose
- Principal Display Panel
160mg, rapid tabs
pain reliever/fever reducer
for ages 6-11
bubble gum flavor
• fast dissolving
• aspirin free
• ibuprofen free
24 rapid tablets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
DOES NOT CONTAIN GLUTEN
** This product is not manufactured or distributed by McNeil Consumer Healthcare,
owner of the registered trademark Junior Strength Tylenol® Meltaways®.
We're committed to your
satisfaction and guarantee
the quality of this product.
Contact us at 1-877-932-7948, or
Please have package available.
DISTRIBUTED BY SUPERVALU INC.
EDEN PRARITE, MN 55344 USA
- INGREDIENTS AND APPEARANCE
ACETAMINOPHEN JUNIOR STRENGTH
acetaminophen tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-450 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 30 (UNII: 2S42T2808B) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) CROSPOVIDONE (UNII: 2S7830E561) Product Characteristics Color PINK Score 2 pieces Shape ROUND Size 16mm Flavor BUBBLE GUM Imprint Code 44;450 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41163-450-08 4 in 1 CARTON 02/25/2005 08/10/2020 1 6 in 1 BLISTER PACK; 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 02/25/2005 08/10/2020 Labeler - SUPERVALU INC. (006961411) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(41163-450) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(41163-450) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(41163-450) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(41163-450) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(41163-450)