Active Ingredients And Purpose
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Dye Free Pain and Fever
- Manufacturer
- Walgreens
- Effective date
- 2024-05-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:12:12
Key Label Information#
Uses
Uses
temporarily reduces fever temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Warnings
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.
Directions And Dosage
Directions
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 use only the enclosed dosing cup designed for with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor find the right dose on chart below. If possible, use weight to dose: otherwise, use age. *or as directed by a doctor Weight (lb) Age (year) Dose (mL)* under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 ml 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL
Other Label Information
Other information
each 5 mL contains :sodium 2 mg store between 20-25ºC (68-77ºF) do not refrigerate see bottom panel for lot number and expiration date
Inactive ingredients
butylparaben, carboxymethylcellulose sodium, citric acid, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Children's Tylenol® Oral Suspension†† Children's Dye-Free Pain & Fever ACETAMINOPHEN 160 mg PER 5 mL PAIN RELIEVER / FEVER REDUCER ORAL SUSPENSION Aspirin Free Alcohol Free Ibuprofen Free AGES 2-11 YEARS FL OZ (mL) Bubble Gum DOSAGE CUP PROVIDED ††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral suspension. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
Label Images#
DailyMed RxNorm Mappings#
| 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0283-04 | Dye Free Pain and FeverChildrens | 118 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 118 | 8 | |
| 0363-0283-04 | Dye Free Pain and FeverChildrens | 1 in 1 BOX | SUSPENSION | 1 | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0283-04 | ML - Milliliter | 0363-0283 | df8d3f21-dd40-44ea-b1a3-169021d636a8 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HIGH FRUCTOSE CORN SYRUP | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
- Dye Free Pain and Fever Childrens
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0283 | 0363-0283-04 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
Complete SPL Sections#
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
temporarily reduces fever temporarily 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.
Directions
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 use only the enclosed dosing cup designed for with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor find the right dose on chart below. If possible, use weight to dose: otherwise, use age. *or as directed by a doctor Weight (lb) Age (year) Dose (mL)* under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 ml 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 15 mL
Other information
each 5 mL contains :sodium 2 mg store between 20-25ºC (68-77ºF) do not refrigerate see bottom panel for lot number and expiration date
Inactive ingredients
butylparaben, carboxymethylcellulose sodium, citric acid, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions or comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Children's Tylenol® Oral Suspension†† Children's Dye-Free Pain & Fever ACETAMINOPHEN 160 mg PER 5 mL PAIN RELIEVER / FEVER REDUCER ORAL SUSPENSION Aspirin Free Alcohol Free Ibuprofen Free AGES 2-11 YEARS FL OZ (mL) Bubble Gum DOSAGE CUP PROVIDED ††This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral suspension. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING . DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
Product Label
WALGREENS Children's Dye-Free Pain & Fever