Indications and uses
reduces fever minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
reduces fever minor aches and pains due to: • the common cold • flu • headache • sore throat • toothache
this product does not contain directions or complete warnings for adult use. do not take more than directed (see overdose warning) shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Attention: For Single-Dose Cups, the entire dose should be taken. Weight (...
(in each 5 mL)
Acetaminophen 160 mg
Acetaminophen
160 mg.............................Pain reliever/fever reducer
• the common cold • flu • headache • sore throat • toothache
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.
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)
• 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.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any sign or symptoms.
Attention: For Single-Dose Cups, the entire dose should be taken.
Weight (lb) Age (yr)Dose (mL)*
under 24 under 2 years ask a doctor
24-35 2-3 years 5 mL
36-47 4-5 years 7.5 mL
48-59 6-8 years 10 mL
60-71 9-10 years 12.5 mL
72-95 11 years 15 mL
*or as directed by a doctor
NDC 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each.
NDC 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each.
Inactive ingredients: acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
Call 1-800-845-8210.
Delivers 5 mL
NDC 0121-0966-05
DYE FREE/GRAPE FLAVOR
Children's Acetaminophen Oral Suspension
160 mg per 5 mL
DYE FREE/GRAPE FLAVOR
Ibuprofen Free/Alcohol Free/Aspirin Free
Pain Reliever-Fever Reducer
SHAKE WELL BEFORE USING
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
SEE INSERT

| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 8 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 8 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 8 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 8 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 8 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 8 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 8 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-0966-00 | Dye Free Childrens Acetaminophen | 10 in 1 CASE | SUSPENSION | 10 | 8 | |
| 0121-0966-00 | Dye Free Childrens Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 8 | |
| 0121-0966-05 | Dye Free Childrens Acetaminophen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 8 | |
| 0121-0966-94 | Dye Free Childrens Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 8 | |
| 0121-0966-94 | Dye Free Childrens Acetaminophen | 3 in 1 CASE | SUSPENSION | 3 | 8 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-0966-00 | ML - Milliliter | 0121-0966 | 24875b41-aea9-4700-8655-d4c10512f1fd | 1 | 2022-04-06 |
| 0121-0966-05 | ML - Milliliter | 0121-0966 | 0653823a-bbba-4745-a69c-73b118f2c985 | 1 | 2022-04-06 |
| 0121-0966-94 | ML - Milliliter | 0121-0966 | c360af38-f12d-4bd7-84c2-0fc30ab9d791 | 1 | 2022-04-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0121-0966 | 0121-0966-05, 0121-0966-94, 0121-0966-00 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
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 |
|---|---|---|---|---|---|---|
| Dye Free Childrens Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | a69fca9d-c0a0-4321-bf03-5c8e99cc07cc | 2025-02-04 | Warnings | 0121-0966-05 0121-0966-94 0121-0966-00 0121-0966 00121096694 00121096605 00121096600 89d3db5b-5a3b-41d3-b2d1-223932ba25d1 a69fca9d-c0a0-4321-bf03-5c8e99cc07cc |
Adverse event summaries are temporarily unavailable. Other product information remains available.