Otc - Active Ingredient
Active ingredient
(in each 5 mL)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Infirst Healthcare Inc. for the product Dr. Cocoa For Children (NDC 62372-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
(in each 5 mL)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses temporarily:
•reduces fever
•relieves minor aches and pains due to:
•the common cold •flu •headache
•sore throat •toothache
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 dose (see overdose warning)
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.
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.
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.
• each 5 mL contains: sodium 4.0 mg
• store between 20-25°C (68-77°F)
• do not use if printed inner seal under cap is torn or missing.
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
Questions or comments?
Call
1-855-848-3284 toll free (English and Spanish)
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
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
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
* Please review the disclaimer below.