Ed-edapapchild 0057

SPL v7

SPL

SPL Set ID f76d5fff-ebea-40f9-aad3-4064a0c863f0

Route

ORAL

Published

Effective Date 2025-12-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Propylparaben Sucralose Fd&c Red No. 40 Methylparaben Polyethylene Glycol, Unspecified Sodium Citrate Citric Acid Monohydrate Water Propylene Glycol

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2012-03-07

Description

Drug Facts

Purpose

Pain Reliever / Fever Reducer

Medication Information

Purpose

Pain Reliever / Fever Reducer

Description

Drug Facts

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
- the common cold
- flu
- headaches
- sore throat
- immunizations
- toothache

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if your child hasliver disease.

Directions

This product does not contain directions or complete warnings for adult use
shake well before using
find right dose on chart below. If possible, use weight to dose: otherwise, use age.
if needed,repeat dose every 4 hours
do not use more than 5 times in 24 hours
do not give more than 5 days unless directed by a doctor.

Weight (lbs.)	Age (yrs.)	Dose (tsp or mL)
under 24	under 2	Ask a doctor
24-35	2-3	1 tsp or 5 mL
36-47	4-5	1 1/2 tsp or 7.5 mL
48-59	6-8	2 tsp or 10 mL
60-71	9-10	2 1/2 tsp or 12.5 mL
72-95	11	3 tsp or 15 mL

Do Not Use

with any other drug containing acetaminophen (prescription or non-prescription). 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.

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.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Other Information

Store at room temperature 15°-30° C (59°-86° F)
Protect from freezing
Protect from Light.
Each teaspoon (5mL) contains:sodium 7 mg

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING.

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.

Inactive Ingredients

Artificial and Natural cherry flavor, citric acid, FD&C Red #40, Methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions? Comments?

Call 1-800-543-9560

When Using This Product

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If

new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 5 days
fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

Active Ingredient (in Each 5ml = 1 Teaspoon)

Acetaminophen 160 mg

Principal Display Panel 236 Ml Bottle Label

NDC 00485-0057-08

ED-APAP

CHILDREN'S

ACETAMINOPHEN

ORAL SOLUTION,

ALCOHOL FREE

CHERRY FLAVORED

Contains 160 mg

Acetaminophen in each

teaspoon (5mL)

8 fl oz (236 ml)

Manufactured for:

EDWARDS

PHARMACEUTICALS, INC.

111 Mulberry Street

RIPLEY, MS 38663

Structured Label Content

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
- the common cold
- flu
- headaches
- sore throat
- immunizations
- toothache

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if your child hasliver disease.

Purpose

Pain Reliever / Fever Reducer

Directions

This product does not contain directions or complete warnings for adult use
shake well before using
find right dose on chart below. If possible, use weight to dose: otherwise, use age.
if needed,repeat dose every 4 hours
do not use more than 5 times in 24 hours
do not give more than 5 days unless directed by a doctor.

Weight (lbs.)	Age (yrs.)	Dose (tsp or mL)
under 24	under 2	Ask a doctor
24-35	2-3	1 tsp or 5 mL
36-47	4-5	1 1/2 tsp or 7.5 mL
48-59	6-8	2 tsp or 10 mL
60-71	9-10	2 1/2 tsp or 12.5 mL
72-95	11	3 tsp or 15 mL

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or non-prescription). 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.

Liver Warning (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.

Overdose Warning (Overdose warning)

Other Information (Other information)

Store at room temperature 15°-30° C (59°-86° F)
Protect from freezing
Protect from Light.
Each teaspoon (5mL) contains:sodium 7 mg

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING.

Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

Artificial and Natural cherry flavor, citric acid, FD&C Red #40, Methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions? Comments? (QUESTIONS? COMMENTS?)

Call 1-800-543-9560

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 5 days
fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

Active Ingredient (in Each 5ml = 1 Teaspoon) (Active ingredient (in each 5mL = 1 teaspoon))

Acetaminophen 160 mg

Principal Display Panel 236 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label)

NDC 00485-0057-08

ED-APAP

CHILDREN'S

ACETAMINOPHEN

ORAL SOLUTION,

ALCOHOL FREE

CHERRY FLAVORED

Contains 160 mg

Acetaminophen in each

teaspoon (5mL)

8 fl oz (236 ml)

Manufactured for:

EDWARDS

PHARMACEUTICALS, INC.

111 Mulberry Street

RIPLEY, MS 38663

Advanced Ingredient Data

[{"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headaches sore throat immunizations toothache", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50568-5": "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.", "50569-3": "Ask a doctor before use if your child has liver disease.", "Purpose": "Pain Reliever / Fever Reducer", "Directions": "This product does not contain directions or complete warnings for adult use shake well before using find right dose on chart below. If possible, use weight to dose: otherwise, use age. if needed,repeat dose every 4 hours do not use more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor. Weight (lbs.) Age (yrs.) Dose (tsp or mL) under 24 under 2 Ask a doctor 24-35 2-3 1 tsp or 5 mL 36-47 4-5 1 1/2 tsp or 7.5 mL 48-59 6-8 2 tsp or 10 mL 60-71 9-10 2 1/2 tsp or 12.5 mL 72-95 11 3 tsp or 15 mL", "Do not use": "with any other drug containing acetaminophen (prescription or non-prescription). 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.", "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.", "Overdose warning": "Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.", "Other information": "Store at room temperature 15°-30° C (59°-86° F) Protect from freezing Protect from Light. Each teaspoon (5mL) contains: sodium 7 mg TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING.", "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.", "Inactive ingredients": "Artificial and Natural cherry flavor, citric acid, FD&C Red #40, Methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose", "QUESTIONS? COMMENTS?": "Call 1-800-543-9560", "When using this product": "do not exceed recommended dose (see overdose warning )", "Stop use and ask a doctor if": "new symptoms occur redness or swelling is present pain gets worse or lasts for more than 5 days fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.", "Active ingredient (in each 5mL = 1 teaspoon)": "Acetaminophen 160 mg", "PRINCIPAL DISPLAY PANEL - 236 ml Bottle Label": "E NDC 00485-0057-08 ED-APAP CHILDREN'S ACETAMINOPHEN ORAL SOLUTION, ALCOHOL FREE CHERRY FLAVORED Contains 160 mg Acetaminophen in each teaspoon (5mL) 8 fl oz (236 ml) Manufactured for: EDWARDS PHARMACEUTICALS, INC. 111 Mulberry Street RIPLEY, MS 38663"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:07:58.906932 · Updated: 2026-03-14T23:12:02.945870