DailyMed - ACETAMINOPHEN suspension

NDC Code(s): 68094-042-01, 68094-042-58
Packager: Precision Dose, Inc.
This is a repackaged label.
Source NDC Code(s): 0113-0212

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated December 4, 2024

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SPL UNCLASSIFIED SECTION
Grape Flavor - 80 mg/2.5 mL 160 mg/5 mL 325 mg/10.15 mL - 650 mg/20.3 mL - For Hospital Use Only - LI1650 Rev. 10/24 - Drug Facts

Grape Flavor

80 mg/2.5 mL 160 mg/5 mL 325 mg/10.15 mL
650 mg/20.3 mL

For Hospital Use Only

LI1650 Rev. 10/24

Drug Facts
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Active ingredient (in each 5 mL)
Acetaminophen 160 mg

Acetaminophen 160 mg
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Purpose
Pain reliever/fever reducer

Pain reliever/fever reducer
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Uses
temporarily: reduces fever - relieves minor aches and pains due to: the common cold - flu - headache - sore throat - toothache
temporarily:
- reduces fever
- relieves minor aches and pains due to:
  - the common cold
  - flu
  - headache
  - sore throat
  - toothache
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Warnings
Liver warning - This product contains acetaminophen. Severe liver damage may occur if - adult takes more than 4,000 mg of acetaminophen in 24 hours - child takes more than 5 doses in 24 hours - taken ...
Liver warning

This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
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 has ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

When using this product do not exceed recommended dose
(see overdose warning)
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
- 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.
- do not give this product to children for pain of arthritis unless directed by a doctor
If pregnant or breast-feeding, ask a health professional before use.

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.

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Directions

Use as directed per healthcare professional. do not take more than directed (see overdose warning) shake well before using - find the right dose on chart below. If possible, use weight to ...

Other information
each 5 mL contains: sodium 3 mg - store at 20-25°C (68-77°F)
- each 5 mL contains: sodium 3 mg
- store at 20-25°C (68-77°F)
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Inactive ingredients
anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and ...

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
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Questions or comments?
1-800-397-9228

1-800-397-9228
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SPL UNCLASSIFIED SECTION
Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free
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How Supplied
NDC 68094-042-58 - 2.5 mL per unit dose ENFit syringe - Fifty (50) syringes per shipper - NDC 68094-038-58 - 5 mL per unit dose ENFit syringe - Fifty (50) syringes per shipper - NDC 68094-130-58 - 2.5 mL ...

NDC 68094-042-58
2.5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipper

NDC 68094-038-58
5 mL per unit dose ENFit syringe
Fifty (50) syringes per shipper

NDC 68094-130-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-231-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-231-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-231-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-330-61
10.15 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-330-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-030-62
20.3 mL per unit dose cup
Thirty (30) cups per shipper
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SPL UNCLASSIFIED SECTION
Packaged By - Precision Dose, Inc. South Beloit, IL 61080 - For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com - LI1650 Rev. 10/24

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1650 Rev. 10/24
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PRINCIPAL DISPLAY PANEL - 2.5 mL Syringe Label
ACETAMINOPHEN ORAL SUSPENSION - 80 mg / 2.5 mL - Delivers 2.5 mL - Store at 20-25°C (68-77°F) Hospital Use Only • Alcohol Free - Aspirin Free • Gluten Free • Ibuprofen Free - For Oral Use Only - Pkg ...

ACETAMINOPHEN ORAL SUSPENSION

80 mg / 2.5 mL
Delivers 2.5 mL

Store at 20-25°C (68-77°F)

Hospital Use Only • Alcohol Free

Aspirin Free • Gluten Free • Ibuprofen Free

For Oral Use Only

Pkg: Precision Dose, Inc. S. Beloit, IL 61080

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Weight (lb)	Age (yr)	Dose (mL)*
* or as directed by a doctor
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
Over 96	Adults and children 12 years and over	20 mL

INGREDIENTS AND APPEARANCE

Product Information

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	RxCUI	RxNorm NAME	RxTTY
1	307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN
2	307668	acetaminophen 32 MG/ML Oral Suspension	SCD
3	307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY
4	307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY
5	307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY
6	307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY
7	307668	APAP 32 MG/ML Oral Suspension	SY

Label: ACETAMINOPHEN suspension

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Liver warning

Allergy alert

Sore throat warning

Do not use

Stop use and ask a doctor if

Overdose warning

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	68094-042-01
2	68094-042-58

Label: ACETAMINOPHEN suspension

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Liver warning

Allergy alert

Sore throat warning

Do not use

Stop use and ask a doctor if

Overdose warning

Find additional resources

Safety

Related Resources

More Info on this Drug

ACETAMINOPHEN suspension

Number of versions: 1

ACETAMINOPHEN suspension

ACETAMINOPHEN suspension

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ACETAMINOPHEN suspension

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.