FDA.reportPublic FDA data

Dr Kids Pain+ Fever Gummies (AFL)

Manufacturer
CalmCo LLC
Effective date
2026-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-07-17 21:36:49

Label at a glance#

ProductDr Kids Pain and Fever
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains due to ■ a common cold/ flu ■ sore throat ■ headache ■ and to reduce fever

Dosage and administration

■ this product does not contain directions or complete warnings for adult use ■ do not exceed 5 doses in a 24-hour period (see liver warning) ■ use dose based on your child's weight or age ■ instruct child to chew thoroughly before swallowing Weight (lbs) Age (years) Dose* (chew) under 24 under 2 do not use 24-35 2 to under 4 2 36-47 4 to under 4 3 48-59 6 to under 9 4 60-71 9 to under 11 4 ot 5 72-95 11 4 to 6 *d...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

__________

Active Ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

.

OTC - PURPOSE SECTION

Active ingredient (in each chewable)Purposes
Acetaminophen 80 mg...............Pain reliever/ fever reducer

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains due to

■ a common cold/ flu

■ sore throat

■ headache

■ and to reduce fever

Warnings

WARNINGS SECTION

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 for this product ■ 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 immediately.

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

OTC - DO NOT USE SECTION

■ with any other product 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

OTC - ASK DOCTOR SECTION

■ liver disease

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

■ taking the blood thinning drug warfarin

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ pain gets worse or lasts more than 5 days

■ fever gets worse or lasts more than 3 days

■ redness or swelling is present

■ any new symptoms appear

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

■ this product does not contain directions or complete warnings for adult use

■ do not exceed 5 doses in a 24-hour period (see liver warning)

■ use dose based on your child's weight or age

■ instruct child to chew thoroughly before swallowing

Weight (lbs)Age (years)Dose* (chew)
under 24under 2do not use
24-352 to under 42
36-474 to under 43
48-596 to under 94
60-719 to under 11

4 ot 5

72-95114 to 6

*dose may be repeated every 4 hours while symptoms persist, up to five times a day or as directed by a doctor.

Other information

OTHER SAFETY INFORMATION

■ store between 68-77°F (20-25°C)

■ avoid high humidity and protect from light

■ do not use if foil seal under cap is torn, broken or missing

■ see bottom of bottle for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

beta cyclodextrin, carrageenan, corn syrup, flavors, purified water, sucralose, sucrose

Questions or comments?

OTC - QUESTIONS SECTION

+1-941-202-3270 (M-F) 9AM-5PM EST or visit www.DrKids.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DK Pain Fever Strawberry 26ctDK Pain Fever Strawberry 26ctDK Pain Fever Pineapple 26ctDK Pain Fever Pineapple 26ct

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73282-253273282-2532-1
73282-253373282-2533-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN SYRUP9G5L16BK6NIACT
ACETAMINOPHEN362O9ITL9DACTIB
CARRAGEENAN5C69YCD2YJIACT
BETADEXJV039JZZ3AIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
CORN SYRUP9G5L16BK6NIACT
ACETAMINOPHEN362O9ITL9DACTIB
CARRAGEENAN5C69YCD2YJIACT
WATER059QF0KO0RIACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT
BETADEXJV039JZZ3AIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC5534a784-a7b1-5599-e063-6294a90a79612026-06-27WarningsExact identifier
ndc (package): 73282-2533-1
ndc (package): 73282-2532-1
ndc (product): 73282-2533
ndc (product): 73282-2532
ndc11 (package): 73282253201
ndc11 (package): 73282253301
spl id: 553c3c6f-d627-4e41-e063-6294a90a59a9
spl set id: 5534a784-a7b1-5599-e063-6294a90a7961

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.