Bactimicina ®

SPL v9

SPL

SPL Set ID bdade270-d813-4178-b594-4951632b6839

Route

ORAL

Published

Effective Date 2022-11-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Fd&c Red No. 40 Corn Syrup Hypromellose, Unspecified Water Citric Acid Monohydrate Sodium Benzoate Sorbitol Glycerin Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-11-17

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

Questions

1-800-858-3889

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; tsp = teaspoonful
find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL or tsp) or as directed by a doctor
Under 24	Under 2 years	Ask a doctor
24-35	2-3 years	5 mL (1 tsp)
36-47	4-5 years	7.5 mL (1½ tsp)
48-59	6-8 years	10 mL (2 tsp)
60-71	9-10 years	12.5 mL (2½ tsp)
72-95	11 years	15 mL (3 tsp)

Attention:use only enclosed dosage cup specifically designed for use with this product. Do not use any other dosing device.

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

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

Other Information

each teaspoon (5 mL) contains:sodium 2 mg
store at room temperature
dosage cup provided
do not use if printed bottle wrap is missing or broken
see bottom panel for lot number and expiration date

Inactive Ingredients

citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxypropyl methycellulose, purified water, sodium benzoate, sorbitol, xanthan gum

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.

Principal Display Panel 118 Ml Bottle Label

Alcohol Free

Voltee Para

Español

TRUSTED SINCE 1978

New Look

Children's

Bactimicina®

Ages 2-11 Years

Acetaminophen 160 mg/5 mL

Pain & Fever

Pain/Fever Reducer

Oral Suspension

Ibuprofen-Free • Asprin Free

Natural

Cherry Flavor

4 FL OZ (118 mL) Dosing Cup Included

Active Ingredient (in Each 5 Ml = 1 Teaspoonful)

Acetaminophen 160 mg

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

Questions

1-800-858-3889

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; tsp = teaspoonful
find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL or tsp) or as directed by a doctor
Under 24	Under 2 years	Ask a doctor
24-35	2-3 years	5 mL (1 tsp)
36-47	4-5 years	7.5 mL (1½ tsp)
48-59	6-8 years	10 mL (2 tsp)
60-71	9-10 years	12.5 mL (2½ tsp)
72-95	11 years	15 mL (3 tsp)

Attention:use only enclosed dosage cup specifically designed for use with this product. Do not use any other dosing device.

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

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)

each teaspoon (5 mL) contains:sodium 2 mg
store at room temperature
dosage cup provided
do not use if printed bottle wrap is missing or broken
see bottom panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxypropyl methycellulose, purified water, sodium benzoate, sorbitol, xanthan gum

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.

Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

Alcohol Free

Voltee Para

Español

TRUSTED SINCE 1978

New Look

Children's

Bactimicina®

Ages 2-11 Years

Acetaminophen 160 mg/5 mL

Pain & Fever

Pain/Fever Reducer

Oral Suspension

Ibuprofen-Free • Asprin Free

Natural

Cherry Flavor

4 FL OZ (118 mL) Dosing Cup Included

Active Ingredient (in Each 5 Ml = 1 Teaspoonful) (Active ingredient (in each 5 mL = 1 teaspoonful))

Acetaminophen 160 mg

Advanced Ingredient Data

[{"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CORN SYRUP", "unii": "9G5L16BK6N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "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", "Questions": "1-800-858-3889", "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; tsp = teaspoonful find the right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL or tsp) or as directed by a doctor Under 24 Under 2 years Ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL (1½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2½ tsp) 72-95 11 years 15 mL (3 tsp) Attention: use only enclosed dosage cup specifically designed for use with this product. Do not use any other dosing device.", "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", "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 for adults as well as for children even if you do not notice any signs or symptoms.", "Other information": "each teaspoon (5 mL) contains: sodium 2 mg store at room temperature dosage cup provided do not use if printed bottle wrap is missing or broken see bottom panel for lot number and expiration date", "Inactive ingredients": "citric acid, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, hydroxypropyl methycellulose, purified water, sodium benzoate, sorbitol, xanthan gum", "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.", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label": "Alcohol Free Voltee Para Español TRUSTED SINCE 1978 New Look Children's Bactimicina® Ages 2-11 Years Acetaminophen 160 mg/5 mL Pain & Fever Pain/Fever Reducer Oral Suspension Ibuprofen-Free • Asprin Free Natural Cherry Flavor 4 FL OZ (118 mL) Dosing Cup Included", "Active ingredient (in each 5 mL = 1 teaspoonful)": "Acetaminophen 160 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:08.896515 · Updated: 2026-03-14T23:12:18.638181