Dr. Cocoa for Children
- Manufacturer
- Infirst Healthcare Inc.
- Effective date
- 2026-01-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:33:13
Label at a glance#
ProductDr. Cocoa for Children Pain and Fever
Active ingredientACETAMINOPHEN
Label structure11 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
(in each 5 mL)
Acetaminophen 160 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
INDICATIONS & USAGE SECTION
Uses temporarily:
•reduces fever
•relieves minor aches and pains due to:
•the common cold •flu •headache
•sore throat •toothache
WARNINGS SECTION
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.
OTC - DO NOT USE SECTION
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.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
OTC - WHEN USING SECTION
When using this product do not exceed recommended dose (see overdose warning)
OTC - STOP USE SECTION
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
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
DOSAGE & ADMINISTRATION SECTION
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.
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.
INACTIVE INGREDIENT SECTION
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
OTC - QUESTIONS SECTION
Questions or comments?
Call
1-855-848-3284 toll free (English and Spanish)
SPL UNCLASSIFIED SECTION
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:
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 1 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 1 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 1 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 1 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62372-200-04 | Dr. Cocoa for ChildrenPain and Fever | 120 mL in 1 BOTTLE | LIQUID | 120 | 1 | |
| 62372-200-04 | Dr. Cocoa for ChildrenPain and Fever | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 62372-200-08 | Dr. Cocoa for ChildrenPain and Fever | 1 in 1 CARTON | LIQUID | 1 | 1 | |
| 62372-200-08 | Dr. Cocoa for ChildrenPain and Fever | 240 mL in 1 BOTTLE | LIQUID | 240 | 1 |
Products#
Every source-derived product name is available through these pages.
- Dr. Cocoa for Children Pain and Fever
- Acetaminophen
- MICROCRYSTALLINE CELLULOSE
- CARBOXYMETHYLCELLULOSE SODIUM
- THEOBROMA CACAO (COCOA) SEED POWDER
- GLYCERIN
- SODIUM BENZOATE
- TRISODIUM CITRATE DIHYDRATE
- WATER
- SUCRALOSE
- SORBITOL SOLUTION
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62372-200 | 62372-200-04, 62372-200-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| THEOBROMA CACAO (COCOA) SEED POWDER | D9108TZ9KG | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| TRISODIUM CITRATE DIHYDRATE | B22547B95K | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Dr. Cocoa for Children Pain and Fever | ACETAMINOPHEN | Infirst Healthcare Inc. | 486ea294-6d18-a907-e063-6294a90ad284 | 2026-01-01 | Warnings | 62372-200-08 62372-200-04 62372-200 62372020008 62372020004 486ea294-6d19-a907-e063-6294a90ad284 486ea294-6d18-a907-e063-6294a90ad284 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.