WELLY CHILDRENS TRAVEL MEDICINE- acetaminophen, calcium carbonate, diphenhydramine hydrochloride 
Welly Health PBC

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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Welly Children's Travel Medicine Kit

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

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

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

 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

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

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

 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

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

 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

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)

Kit

Package Labeling:(72663-233-49)

Label

Package Labeling:(72663-225-49)

Label2

Package Labeling:(72663-347-49)

Label3

WELLY CHILDRENS TRAVEL MEDICINE 
acetaminophen, calcium carbonate, diphenhydramine hydrochloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-203
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72663-203-491 in 1 KIT04/06/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 12 
Part 22 BLISTER PACK 12 
Part 32 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 AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScore2 pieces
ShapeROUNDSize16mm
FlavorImprint Code 44449
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72663-233-492 in 1 KIT
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/06/2020
Part 2 of 3
CHILDRENS STOMACH SOOTHER 
calcium carbonate tablet, chewable
Product Information
Item Code (Source)NDC:72663-225
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION400 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpinkScoreno score
ShapeROUNDSize16mm
FlavorImprint Code 44596
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72663-225-492 in 1 KIT
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/06/2020
Part 3 of 3
CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride tablet, chewable
Product Information
Item Code (Source)NDC:72663-347
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScoreno score
ShapeROUNDSize12mm
FlavorImprint Code 44585
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72663-347-492 in 1 KIT
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/06/2020
Labeler - Welly Health PBC (116766884)

Revised: 4/2020
Document Id: a359ac07-b87f-2440-e053-2a95a90a4b16
Set id: ebe7a83b-8ee3-444a-a983-e5e1f0273e14
Version: 2
Effective Time: 20200415
 
Welly Health PBC