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NDC 76281-0327-26 Childrens Pain and Fever 160 mg/5mL Details
Childrens Pain and Fever 160 mg/5mL
Childrens Pain and Fever is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by AptaPharma Inc.. The primary component is ACETAMINOPHEN.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 76281-0327-26Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
NDC | 76281-0327 |
---|---|
Product ID | 76281-327_940c1f54-2f20-4f6d-97b5-2fd20249e29e |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Childrens Pain and Fever |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | ACETAMINOPHEN |
Product Type | HUMAN OTC DRUG |
Dosage Form | SUSPENSION |
Route | ORAL |
Active Ingredient Strength | 160 |
Active Ingredient Units | mg/5mL |
Substance Name | ACETAMINOPHEN |
Labeler Name | AptaPharma Inc. |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part343 |
Listing Certified Through | 2022-12-31 |
Package
Package Images


NDC 76281-0327-26 (76281032726)
NDC Package Code | 76281-327-26 |
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Billing NDC | 76281032726 |
Package | 1 BOTTLE in 1 CARTON (76281-327-26) / 237 mL in 1 BOTTLE |
Marketing Start Date | 2021-05-04 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2c04ef82-6297-4f4a-a2d5-4f6016a52c40 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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 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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if
SPL UNCLASSIFIED SECTION
Overdose warning
SPL UNCLASSIFIED SECTION
Directions
- this product does not contain directions or complete warnings for adult use.
- shake well before using
- mL = milliter; tsp = teaspoon
- find right dose on chart below. If possible, use weight to dose; otherwise , use age.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor.
Weight (lb) | Age (yr) | Dose (mL or tsp)* |
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 (1 1/2 tsp) |
48 - 59 | 6 - 8 years | 10 mL (2 tsp) |
60 - 71 | 9 - 10 years | 12.5 mL ( 2 1/2 tsp) |
72 - 95 | 11 years | 15 mL (3 tsp) |
* or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other information
SPL UNCLASSIFIED SECTION
Package Labeling
CVS
Health®
Compare to the active
ingredient in Children's
Tylenol® Oral Suspension**
Suspension Liquid
NDC 76281-327-26
Children's Pain &
Fever
ACETAMINOPHEN
160 mg / 5 mL
Pain reliever;
Fever reducer
For ages 2 to
11 years
Free of:
- Added alcohol
- Aspirin
- Ibuprofen
CHERRY FLAVOR
Use ONLY Enclosed Dosing Cup
8 FL OZ (237 mL)
**This product is not manufactured or distrubuted
by McNeil Consumer Healthcare, distributor of
Children's Tylenol® Oral Suspension.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2021 CVS/pharmacy
CVS.com® 1-800-SHOP CVS V-37464
BX-125
DO NOT USE IF PRINTED NECK BAND IS
BROKEN OR MISSING
res
INGREDIENTS AND APPEARANCE
CHILDRENS PAIN AND FEVER
acetaminophen suspension |
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Labeler - AptaPharma Inc. (790523323) |