ACETAMINOPHEN RAPID TABS JUNIOR- acetaminophen tablet, chewable
Family Dollar Services 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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Family Wellness 44-450-Delisted

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- headache
- sore throat
- flu
- toothache
- the common cold
temporarily reduces fever

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 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

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 dosage.

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 use
do not give more than directed
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 doctor

Other information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
avoid high humidity
see end flap for expiration date and lot number

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, sucralose

Questions or comments?

1-800-426-9391

Product Packaging

NDC 55319-450-08
FAMILY wellness™

COMPARE TO THE ACTIVE INGREDIENT OF JR. TYLENOL® MELTAWAYS®*

AGES 6-11
Junior
Acetaminophen
Rapid Tabs
Acetaminophen
Pain Reliever/Fever Reducer
Aspirin Free, Ibuprofen Free

24 BUBBLE GUM FLAVORED
CHEWABLE TABLETS
160 mg Each

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Jr. Tylenol® Meltaways®.
50844 REV0416D45008

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

DISTRIBUTED BY:
FAMILY DOLLAR SERVICES, INC.,
10401 MONROE RD,
MATTHEWS, NC 28105 USA

Family Wellness 44-450

ACETAMINOPHEN RAPID TABS JUNIOR
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55319-450
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	16mm
Flavor	BUBBLE GUM	Imprint Code	44;450
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55319-450-08	4 in 1 CARTON	02/25/2005	04/10/2020
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	02/25/2005	04/10/2020

Labeler - Family Dollar Services Inc (024472631)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(55319-450)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(55319-450)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(55319-450)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(55319-450)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(55319-450)

Revised: 9/2017

Document Id: 9f204394-23b2-4594-a83e-4c51a87d7088

Set id: aed88aff-eaaa-4c43-8e1a-bd7704ae4d0d

Version: 12

Effective Time: 20170925

Family Dollar Services Inc