FDA Label for Healthy Mama Eazzze The Pain
View Indications, Usage & Precautions
- 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
Healthy Mama Eazzze The Pain Product Label
The following document was submitted to the FDA by the labeler of this product Maternal Science, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Directions
- Do not take more than directed(see overdose warning)
Adults and children 12 years and over: Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours
Children under 12 years: Do not use this adult product in children under 12 years of age: this will provide more than the
recommended dose(overdose) and may cause liver damage.
Other Information
- Store at room temperature
Inactive Ingredients
Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.
Questions?
If you have any questions or comments. or to report an adverse event, please contact (xxx) xxx-xxxx.
Principal Display Panel
healthy
mama
eaZZZe THE PAIN!
acetaminophen 500mg diphenhydramine HCl 25 mg
PAIN RELIEVER AND NIGHTTIME AID
extra strength aspirin free
40 caplets
* Please review the disclaimer below.