Healthy Mama
FDA Label NDC 58154-104

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Maternal Science, Llc for the product Healthy Mama (NDC 58154-104). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each caplet), purposes, uses, warnings, when using this prodcut, otc - keep out of reach of children, do not use, ask a doctor before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Caplet)

→ Purposes

→ Uses

→ Warnings

→ When Using This Prodcut

→ Otc - Keep Out Of Reach Of Children

→ Do Not Use

→ Ask A Doctor Before Use If You Are

→ Ask A Doctor Or Pharmacist Before Use If You Are

→ Stop Use And Ask A Doctor If

→ Otc - Pregnancy Or Breast Feeding

→ Overdose Warning

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

Active Ingredient (In Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25mg

Purposes

Pain RelieverNighttime Sleep Aid

Uses

Temporary relief of occasional headaches and minor aches with pains with accompanying sleeplessness.

Warnings

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

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks everyday while using this product

When Using This Prodcut

drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.
In children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
if you have ever had an allergic reaction to this product or any of its ingredients

Ask A Doctor Before Use If You Are

liver disease
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Stop Use And Ask A Doctor If

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
pain gets worse or lasts more than 10 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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

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.(1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.