Crossing Well Health Pedia Care Pain + Fever Drug Facts

SPL v3

SPL

SPL Set ID e069060f-fbb2-4c7a-b872-00b3ab86d01b

Route

ORAL

Published

Effective Date 2023-06-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Anhydrous Citric Acid Carboxymethylcellulose Sodium, Unspecified Glycerin Microcrystalline Cellulose Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-05-26

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
- headache
- sore throat
- toothache

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50567-7

When using this product do not exceed recommended dose (see overdose warning)

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.
do not give more than directed (see overdose warning)
shake well before using
mL = milliliter
find right dose on chart. If possible, use weight to dose; otherwise, use age.
remove the child protective cap and squeeze your child’s dose into the dosing cup
do not give more than 5 times in 24 hours

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

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

Questions?

1-866-467-2748

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

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 for children even if you do not notice any signs or symptoms.

Other Information

very low sodium
store at room temperature

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum

Principal Display Panel

NDC 52412-912-01

Fast Acting

Pedia Care®

100% dedicated to kids™

Infants

ACETAMINOPHEN

Pain Reliever / Fever Reducer

Acetaminophen (160mg per 5 mL)

Oral Suspension

No Added Alcohol
Ibuprofen Free
Aspirin Free
No Parabens

Natural Grape Flavor

(Use only Enclosed Syringe)

1FL OZ ( 30mL)

160 mg per 5 mL

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING

IMPORTANT: Keep this carton for future reference on full labeling.

Package Label of 1 FLOZ (30 mL)

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.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Package Label of 4 Floz (118 Ml)

Structured Label Content

Uses

temporarily:

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50567-7 (50567-7)

When using this product do not exceed recommended dose (see overdose warning)

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.
do not give more than directed (see overdose warning)
shake well before using
mL = milliliter
find right dose on chart. If possible, use weight to dose; otherwise, use age.
remove the child protective cap and squeeze your child’s dose into the dosing cup
do not give more than 5 times in 24 hours

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

Do Not Use (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

Questions?

1-866-467-2748

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)

very low sodium
store at room temperature

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 52412-912-01

Fast Acting

Pedia Care®

100% dedicated to kids™

Infants

ACETAMINOPHEN

Pain Reliever / Fever Reducer

Acetaminophen (160mg per 5 mL)

Oral Suspension

No Added Alcohol
Ibuprofen Free
Aspirin Free
No Parabens

Natural Grape Flavor

(Use only Enclosed Syringe)

1FL OZ ( 30mL)

160 mg per 5 mL

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING

IMPORTANT: Keep this carton for future reference on full labeling.

Package Label of 1 FLOZ (30 mL)

Stop Use and Ask A Doctor If (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.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 160 mg

Package Label of 4 Floz (118 Ml) (Package Label of 4 FLOZ (118 mL))

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not exceed recommended dose (see overdose warning )", "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. do not give more than directed ( see overdose warning ) shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise, use age. remove the child protective cap and squeeze your child’s dose into the dosing cup do not give more than 5 times in 24 hours 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", "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", "Questions?": "1-866-467-2748", "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": "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 for children even if you do not notice any signs or symptoms.", "Other information": "very low sodium store at room temperature", "Inactive ingredients": "anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, microcrystalline cellulose, sodium benzoate, purified water, sodium citrate dihydrate, sorbitol liquid, sucralose, xanthan gum", "PRINCIPAL DISPLAY PANEL": "NDC 52412-912-01 Fast Acting Pedia Care® 100% dedicated to kids™ Infants ACETAMINOPHEN Pain Reliever / Fever Reducer Acetaminophen (160mg per 5 mL) Oral Suspension No Added Alcohol Ibuprofen Free Aspirin Free No Parabens Natural Grape Flavor (Use only Enclosed Syringe) 1 FL OZ ( 30 mL) 160 mg per 5 mL TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING IMPORTANT: Keep this carton for future reference on full labeling. Package Label of 1 FLOZ (30 mL)", "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.", "Active ingredient (in each 5 mL)": "Acetaminophen 160 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:46.289039 · Updated: 2026-03-14T23:09:44.239716