Dr. Cocoa For Children, Pain & Fever

Dr. Cocoa For Children, Pain & Fever
SPL v1
SPL
SPL Set ID 486ea294-6d18-a907-e063-6294a90ad284
Route
ORAL
Published
Effective Date 2025-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Microcrystalline Cellulose Carboxymethylcellulose Sodium Theobroma Cacao (cocoa) Seed Powder Glycerin Sodium Benzoate Trisodium Citrate Dihydrate Water Sucralose Sorbitol Solution Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-20

Description

Active ingredient (in each 5 mL) Acetaminophen 160 mg


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses temporarily:

•reduces fever

•relieves minor aches and pains due to:

•the common cold •flu •headache

•sore throat •toothache

Dosage and Administration

Directions

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

• do not give more than directed (see overdose warning)

• shake well before using

• mL = milliliter

• find right dose on chart below. If possible, use weight todose; otherwise, use age.

• remove the child protective cap and pour your child'sdose into the dosing cup

• repeat dose every 4 hours while symptoms last

• do not give more than 5 times in 24 hours

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Description

Active ingredient (in each 5 mL) Acetaminophen 160 mg

Section 42229-5

infirst +

HEALTHCARE

Manufactured for: Infirst Healthcare Inc., Westport, CT 06880

©2025 Infirst Healthcare Inc.

FLAVORED WITH REAL COCOA

No Parabens.

Free from Synthetic Dyes.

Please visit our website at:

www.DrCocoa.com

Section 50565-1

Keep out of reach of children.

Overdose warning

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

Section 50566-9

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

Section 50567-7

When using this product do not exceed recommended dose (see overdose warning)

Section 50568-5

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if your child has liver disease

Section 50570-1

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.

Section 51727-6

Inactive ingredients

anhydrous citric acid, benzyl alcohol, caramel, carboxymethylcellulose sodium, cocoa powder, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Section 53413-1

Questions or comments?

Call 1-855-848-3284 toll free (English and Spanish)

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

4 Oz Label

Dr. Cocoa ®

for Children

Pain + Fever

Acetaminophen (160 mg per 5 ml)

Oral Suspension

Pain Reliever-Fever Reducer

FLAVORED WITH REAL COCOA

Great Chocolate Flavor

Ages 2-11

4 FL OZ (120 mL)

160 mg per 5 mL

8 Oz Label

Dr. Cocoa®

for Children

Pain + Fever

Acetaminophen (160 mg per 5 ml)

Oral Suspension

Pain Reliever-Fever Reducer

FLAVORED WITH REAL COCOA

Great Chocolate Flavor

Ages 2-11

8 FL OZ (240 mL)

160 mg per 5 mL

Other Information

• each 5 mL contains: sodium 4.0 mg

• store between 20-25ºC (68-77ºF)

• do not use if printed inner seal under cap is torn or missing.


Structured Label Content

Indications and Usage (34067-9)

Uses temporarily:

•reduces fever

•relieves minor aches and pains due to:

•the common cold •flu •headache

•sore throat •toothache

Dosage and Administration (34068-7)

Directions

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

• do not give more than directed (see overdose warning)

• shake well before using

• mL = milliliter

• find right dose on chart below. If possible, use weight todose; otherwise, use age.

• remove the child protective cap and pour your child'sdose into the dosing cup

• repeat dose every 4 hours while symptoms last

• do not give more than 5 times in 24 hours

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

infirst +

HEALTHCARE

Manufactured for: Infirst Healthcare Inc., Westport, CT 06880

©2025 Infirst Healthcare Inc.

FLAVORED WITH REAL COCOA

No Parabens.

Free from Synthetic Dyes.

Please visit our website at:

www.DrCocoa.com

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose (see overdose warning)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if your child has liver disease

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, benzyl alcohol, caramel, carboxymethylcellulose sodium, cocoa powder, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Section 53413-1 (53413-1)

Questions or comments?

Call 1-855-848-3284 toll free (English and Spanish)

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient

(in each 5 mL)

Acetaminophen 160 mg

4 Oz Label (4 oz label)

Dr. Cocoa ®

for Children

Pain + Fever

Acetaminophen (160 mg per 5 ml)

Oral Suspension

Pain Reliever-Fever Reducer

FLAVORED WITH REAL COCOA

Great Chocolate Flavor

Ages 2-11

4 FL OZ (120 mL)

160 mg per 5 mL

8 Oz Label (8 oz label)

Dr. Cocoa®

for Children

Pain + Fever

Acetaminophen (160 mg per 5 ml)

Oral Suspension

Pain Reliever-Fever Reducer

FLAVORED WITH REAL COCOA

Great Chocolate Flavor

Ages 2-11

8 FL OZ (240 mL)

160 mg per 5 mL

Other Information (Other information)

• each 5 mL contains: sodium 4.0 mg

• store between 20-25ºC (68-77ºF)

• do not use if printed inner seal under cap is torn or missing.


Advanced Ingredient Data


Raw Label Data

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