Drugplain

Infants 20 mg/.3mL

Simethicone · SUSPENSION/ DROPS · RUGBY LABORATORIES

No Recall History
Plain English

Infants is a suspension/ drops containing simethicone at 20 mg/.3mL, taken oral. Manufactured by RUGBY LABORATORIES.

Key Facts

Brand Name
Infants
Generic Name
Simethicone
NDC Code (Product)
0536-1303
Manufacturer
RUGBY LABORATORIES
Strength
20 mg/.3mL
Dosage Form
SUSPENSION/ DROPS
Route
ORAL
Marketing Status
Application #
M002
Marketing Start
09/01/2020

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE(S) temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches

Dosage & Administration

DIRECTIONS this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using find right dose on chart below. If possible, use weight to dose; otherwise use age. mL=milliliter measure with dosing device provided. Do not use any other dosing device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart WEIGHT (lb) AGE (mos) DOSE (mL) under 6 mos ask a doctor 12-17 lbs 6-11 mos 1.25 mL 18-23 lbs 12-23 years 1.875 mL

Warnings

WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Frequently Asked Questions

What is Infants used for?

Infants contains Simethicone. It is a suspension/ drops taken oral. Consult your doctor for specific uses.

Is Infants a controlled substance?

Infants is not classified as a controlled substance by the DEA.

What is the generic name for Infants?

The generic name for Infants is Simethicone. There are 11 other brand versions of Simethicone.

What is the NDC code for Infants 20 mg/.3mL?

The NDC (National Drug Code) for Infants 20 mg/.3mL is 0536-1303, listed by RUGBY LABORATORIES.