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Fast Acting

Crossing well Health Pedia Care Pain + Fever Drug Facts

Approved
Approval ID

e069060f-fbb2-4c7a-b872-00b3ab86d01b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Randob Labs., Ltd.

DUNS: 061995007

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ACETAMINOPHEN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52412-912
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (11)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ACETAMINOPHENActive
Quantity: 160 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/10/2023

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)

Crossing Well Health Fast Acting Pedia Care Grape Flavor 1 FL OZ 30 ml

Package Label of 4 FLOZ (118 mL)

Crossing Well Health Fast Acting Pedia Care Grape Flavor 4 FL OZ 118 ml

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/10/2023

Uses

temporarily:

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/10/2023

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/10/2023

Questions?

1-866-467-2748

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/10/2023

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/10/2023

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/10/2023

Purpose

Pain reliever/fever reducer

WARNINGS SECTION

LOINC: 34071-1Updated: 6/10/2023

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.

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

Ask a doctor before use if your child hasliver disease

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

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

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.

Keep out of reach of children.

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/13/2025

Directions

this product does not contain directions or complete warnings for adult use. do not give more than directed (seeoverdose 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

**Attention:**use only enclosed dosing cupl specifically designed for use with this product.

Do not use any other dosing device.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/10/2023

Other information

  • very low sodium
  • store at room temperature

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Fast Acting - FDA Drug Approval Details