WELLY CHILDRENS TRAVEL MEDICINE- acetaminophen, calcium carbonate, diphenhydramine hydrochloride kit

Welly Childrens Travel Medicine by

Drug Labeling and Warnings

Welly Childrens Travel Medicine by is a Otc medication manufactured, distributed, or labeled by Welly Health PBC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Children's Pain and Fever Relief, 12 tablets

Drug Facts

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain Reliever/ Fever Reducer

Uses

• for the temporary relief of minor aches and pains associated with
• the common cold
• sore throat
• headache
• toothache
• flu
• and to reduce 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 acetominophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If 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.

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.

Stop use and ask a doctor if

• pain persists for more than 5 days or gets worse
• fever persists for more than 3 days or gets worse.
• 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 overdose, get medical help or contact a Poison Control Center right away. Prompt 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 give more than directed
• find the right dose on the chart below. If possible, use weight to dose; otherwise, use age.
• chew or crush tablets completely before swallowing; do not swallow tablets whole
• 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 (chewable tablets)*
Under 24	Under 2	Ask a doctor
24-35	2-3	1 tablet
36-47	4-5	1 1/2 tablets
48-59	6-8	2 tablets
60-71	9-10	2 1/2 tablets
72-95	11	3 tablets

*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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• avoid high humidity
• see label for expiration date and lot number
• use by expiration date on package

Inactive ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

1-833-BE-WELLY (1-833-239-3559)

Children's Stomach Soother, 12 tablets

Drug Facts

Active ingredient (in each tablet)

Calcium carbonate 400 mg

Purpose

Antacid

Uses

for the relief of

• heartburn
• sour stomach
• acid indigestion
• upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

• do not take more than 3 chewable tablets (ages 2-5) or 6 chewable tablets (ages 6-11) in a 24-hour period
• do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor

Directions

• find the right dose on the chart on the next page based on weight (preferred); otherwise use age
• chew or crush tablets completely before swallowing; do not swallow tablets whole
• repeat dose as needed, not more than 3 times a day

Weight (lb)	Age (yr)	Dose (chewable tablets)*
under 24	under 2	ask a doctor
24-47	2-5	1 tablet
48-95	6-11	2 tablets

*or as directed by a doctor

Other information

• Each chewable tablet contains: calcium 160 mg
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• avoid excessive humidity
• see label for expiration date and lot number
• use by expiration date on package

Inactive Ingredients

acacia, cornstarch, D&C red# 27 aluminum lake, D&C red #30 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, silicon dioxide, sodium lauryl sulfate, sucrose, talc

Questions or comments?

1-833-BE-WELLY (1-833-239-3559)

Children's Allergy Relief, 12 tablets

Drug Facts

Active ingredient (in each chewable tablet)

Diphenhydramine HCI 12.5 mg

Purpose

Antihistamine

Use

temporarily relieves runny nose and relieves sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies.

Warnings

Do not use

• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• may cause excitability in children
• may cause marked drowsiness; alcohol, sedatives, and traquilizers may increase the drowsiness effect
• avoid alcoholic beverages
• use caution when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• find right dose on the chart below
• chew or crush tablets completely before swallowing; do not swallow tablets whole
• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 times in 24 hours

• Adults and children 12 years of age and over: 2 to 4 chewable tablets (25 to 50 mg)
• Children 6 to under 12 years of age: 1 to 2 chewable tablets (12.5 to 25 mg)
• Children under 6 years of age: Consult a doctor

Other information

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

Inactive Ingredients

D&C Red #27 Aluminum Lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C Blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

Questions or comments?

1-833-BE-WELLY (1-833-239-3559)

Package Labeling:(

72663-203-49)

Package Labeling:(

72663-233-49)

Package Labeling:(

72663-225-49)

Package Labeling:(

72663-347-49)

INGREDIENTS AND APPEARANCE

WELLY CHILDRENS TRAVEL MEDICINE 
acetaminophen, calcium carbonate, diphenhydramine hydrochloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72663-203

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-203-49	1 in 1 KIT	04/06/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BLISTER PACK	12
Part 2	2 BLISTER PACK	12
Part 3	2 BLISTER PACK	12

Part 1 of 3

CHILDRENS PAIN AND FEVER RELIEF 
acetaminophen tablet, chewable

Product Information
Item Code (Source)	NDC: 72663-233
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)
CROSPOVIDONE (UNII: 2S7830E561)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 30 (UNII: 2S42T2808B)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	purple	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor		Imprint Code	44449
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-233-49	2 in 1 KIT
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	04/06/2020

Part 2 of 3

CHILDRENS STOMACH SOOTHER 
calcium carbonate tablet, chewable

Product Information
Item Code (Source)	NDC: 72663-225
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	400 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	16mm
Flavor		Imprint Code	44596
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-225-49	2 in 1 KIT
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 final	part331	04/06/2020

Part 3 of 3

CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, chewable

Product Information
Item Code (Source)	NDC: 72663-347
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 (UNII: 2S42T2808B)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
METHYL SALICYLATE (UNII: LAV5U5022Y)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	purple	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	44585
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72663-347-49	2 in 1 KIT
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	part348	04/06/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	04/06/2020

Labeler - Welly Health PBC (116766884)