CHILDRENS SILAPAP- acetaminophen liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
ATLANTIC BIOLOGICALS CORP.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose: Pain reliever/fever reducer Uses To reduce fever and for the temporary relief of minor aches and pains due to: - Headache - Muscular aches - Backache - Minor pain of arthritis - The common cold - Toothache - Premenstrual and menstrual cramps
Authorization status:
OTC monograph not final
Authorization number:
17856-0141-1, 17856-0141-2, 17856-0141-3, 17856-0141-4, 17856-0141-5, 17856-0141-6, 17856-0141-7, 17856-0141-8

CHILDRENS SILAPAP- acetaminophen liquid

ATLANTIC BIOLOGICALS CORP.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Children's Silapap Liquid

Active Ingredient: Acetaminophen 160 mg (in each 5 mL (TSP))

Purpose: Pain reliever/fever reducer

Uses To reduce fever and for the temporary relief of minor aches and pains due to:

Headache

Muscular aches

Backache

Minor pain of arthritis

The common cold

Toothache

Premenstrual and menstrual cramps

Warnings

Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:

more than 5 doses in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

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.

Alcohol warning:If the user consumes 3 or more alcoholic drinks every day, ask your doctor whether

you should take acetaminophen or other pain relievers/fever reducers.

Do not use

with any other product drug containing acetaminophen (prescription or nonprescription). If you are

not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

if the user is allergic to acetaminophen or any of the inactive ingredients in this product

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

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 (1800-

222-1222) right away. Quick medical attention is critical even if you do not notice any signs of

symptoms.

Directions

do not take more than directed (see overdose warning).

if needed, repeat dose every 4 hours or as directed by a doctor

do not give more than 5 doses in 24 hours

children under 2 yrs (under 24 lbs) ask a doctor

children 2-3 years (24-35 lbs)

1 teaspoonful (TSP)(5 mL)

children 4-5 years (36-47 lbs)

1 1/2 teaspoonfuls (TSP)(7.5 mL)

children 6-8 years (48-59 lbs)

2 teaspoonfuls (TSP)(10 mL)

children 9-10 years (60-71 lbs)

2 1/2 teaspoonfuls (TSP)(12.5 mL)

children 11 years (72-95 lbs)

3 teaspoonfuls (TSP)(15 mL)

adults & children 12 years & older 4 teaspoonfuls (TSP)(20 mL)

Other information

Store at room temperature 20°-25°C (68°-77°F)

Inactive ingredients

citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol,

saccharin sodium, sodium benzoate, and purified water.

Ques tions

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PLACE

MIAMI, FL 33179

ACETAMINOPHEN (SILAPAP)

CHILDRENS SILAPAP

acetaminophen liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:178 56 -0 141(NDC:548 38 -144)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

16 0 mg in 5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

CHERRY (cherry flavo r)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:178 56 -0 141-

50 in 1 BOX, UNIT-DOSE

0 4/0 4/20 19

1

20 .31 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:178 56 -0 141-

50 in 1 BOX, UNIT-DOSE

0 4/0 4/20 19

2

31.25 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

3

NDC:178 56 -0 141-

50 in 1 BOX, UNIT-DOSE

0 4/0 4/20 19

3

15.6 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

4

NDC:178 56 -0 141-

120 in 1 BOX, UNIT-DOSE

0 4/0 4/20 19

4

2.5 mL in 1 SYRINGE; Type 0 : No t a Co mbinatio n Pro duct

5

NDC:178 56 -0 141-

72 in 1 BOX, UNIT-DOSE

0 4/0 4/20 19

5

5 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n Pro duct

6

NDC:178 56 -0 141-

48 in 1 BOX, UNIT-DOSE

0 4/0 4/20 19

6

5 mL in 1 SYRINGE; Type 0 : No t a Co mbinatio n Pro duct

7

NDC:178 56 -0 141-

120 in 1 BOX, UNIT-DOSE

0 4/0 4/20 19

7

1.25 mL in 1 SYRINGE; Type 0 : No t a Co mbinatio n Pro duct

8

NDC:178 56 -0 141-

120 in 1 BOX, UNIT-DOSE

0 4/0 4/20 19

8

2.5 mL in 1 SYRINGE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part343

0 4/0 4/20 19

ATLANTIC BIOLOGICALS CORP.

Labeler -

AT LANT IC BIOLOGICALS CORP. (047437707)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

ATLANTIC BIOLOGICALS CORP.

0 4743770 7

relabel(178 56 -0 141) , repack(178 56 -0 141)

Revised: 4/2019

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