FDA Label for Little Remedies New Baby Essentials

Active Ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever / Fever reducer

Antigas

Uses

Temporarily:

• reduces fever
  
• relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache.

Relieves discomfort of infant gas frequently caused by excessive swallowing of air or certain formulas or food

–Helps loosen mucus secretions to aid aspiration and removal from nose and sinuses, allowing for easier breathing. For infants this can be assisted with the use of our specially designed “Soft Tip” Nasal Aspirator.

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.

Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

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.

Do Not Use

• with any other products containing acetaminophen (prescription or non-prescription).

      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.

Ask A Doctor Before Use If The Child Has

liver disease.

Ask A Doctor Or Pharmacist Before Use If The Child 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

• new symptoms occur
  
• fever gets worse or lasts more than 3 days
  
• pain gets worse or lasts more than 5 days
  
• redness or swelling is present. These could be signs of a serious condition.

Keep Out Of Reach Of Children.

Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

In some infants, a rare allergic reaction may occur. Do not exceed recommended dosage.

▪ The use of this dispenser by more than one person may spread infection.

▪ Wipe nozzle clean after each use.

Directions

This product does not contain directions or complete warnings for adult use.

• Shake well before using
  
• Find the right dose on the chart on the chart below. If possible, use weight to determine dose; otherwise, use age.
  
• Only use the enclosed AccuSafe® syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.  
  
• Remove cap, insert syringe to flow restrictor and invert bottle
  
• Pull back syringe until filled to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek)
  
• If needed, repeat dose every 4 hours while symptoms last
  
• Do not give more than 5 times in any 24-hour period (see overdose warning)
  
• Do not give more than 5 days unless directed by a doctor
  
• Replace cap tightly to maintain child resistance

mL = milliliter

Weight (lbs)	Age (yrs)	Dose (mL)
Under 24	under 2	Ask a doctor
24-35	2-3	5 mL

■ shake well before using

■ only use enclosed syringe; fill to prescribed level and dispense liquid slowly into child’s mouth, toward inner cheek

■ all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. Do not exceed 12 doses per day.

■ dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids

■ for best results, clean syringe after each use and replace original cap

If possible, use weight to determine dose; otherwise use age.

mL = milliliters

Age (yrs)	Weight (lbs)	Dose
Newborns & Infants under 2 years	under 24	0.3 mL
Children 2 years and over	24 and over	0.6 mL

(For nasal use only)

▪ Infants: 2 to 6 drops in each nostril as often as needed or as directed by your doctor. 

▪Children: 2 to 6 sprays or drops into each nostril as often as needed or as directed by a doctor.

Store at 20°-25°C (68°-77°F).

See bottle for lot and expiration date.

Other Information

• Store at 20°-25°C (68°-77°F)  
  
• AccuSafe® Oral dosing device enclosed
  
• Check expiration date on bottle or box before using.

■ do not freeze ■ store at room temperature 20˚-25˚C (68˚-77˚F)

■ See bottle or box for lot number and expiration date

Inactive Ingredients

benzoic acid, carboxymethylcellulose, glycerin, natural grape flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum

FOR DIAPER RASH
BOUDREAUX’S BUTT PASTE ® Diaper Rash Ointment

FOR TUMMYS^TM

GAS RELIEF DROPS Simethicone / Antigas

Drug Facts

carmellose sodium,citric acid, microcrystalline cellulose, natural strawberry flavor, propylene glycol, purified water, sodium benzoate, sucralose, xanthan gum

FOR TUMMYS^TM

GRIPE WATER

Active Ingredient (In Each 0.3 Ml)

Simethicone Emulsion USP 66.7 mg/ Simethicone 20 mg

Other Ingredients

purified water, agave, glycerin, natural ginger flavor, potassium sorbate, citric acid, xanthan gum

SHAKE WELL. May be taken directly using the dispenser included. May be given up to six times in a 24 hour period. If necessary to repeat dosage, wait a minimum of 30 minutes. Do not use if safety seal is broken or missing.

Do Not Use If

▪ child has a history of kidney failure or renal problems ▪ child is allergic to any of the ingredients in this product Always consult your health care provider before giving this or any supplement to an infant. ▪ Store at room temperature.

FOR NOSES^TM

SALINE SPRAY + DROPS 

Ingredients:

water, sodium chloride, glycerin, sodium benzoate, benzoic acid

Principal Display Panel

Little Remedies®

New Baby Essentials Kit

INFANT FEVER/PAIN RELIEVER

ACETAMINOPHEN / FEVER/PAIN RELIEVER

2 FL OZ (59 mL)

Syringe Included

GAS DROPS

SIMETHICONE /ANTIGAS

1 FL OZ (30 mL)

Syringe Included

DIAPER RASH OINTMENT

ZINC OXIDE / SKIN PROTECTANT

2 OZ (57 g)

SALINE SPRAY + DROPS

0.5 FL OZ (15 mL)

GRIPE WATER

GINGER / FENNEL SUPPLEMENT

2 FL OZ (59 mL)

Syringe Included

Nasal Aspirator

PRINCIPAL DISPLAY PANELLittle Remedies®New Baby Essentials KitINFANT FEVER/PAIN RELIEVER ACETAMINOPHEN / FEVER/PAIN RELIEVER 2 FL OZ (59 mL)Syringe IncludedGAS DROPSSIMETHICONE /ANTIGAS1 FL OZ (30 mL)Syringe IncludedDIAPER RASH OINTMENT ZINC OXIDE / SKIN PROTECTANT 2 OZ (57 g) SALINE SPRAY + DROPS 0.5 FL OZ (15 mL)GRIPE WATER GINGER / FENNEL SUPPLEMENT2 FL OZ (59 mL)Syringe IncludedNasal Aspirator - little remedies new baby essentials kit 01