NONPRESCRIPTION DRUGS

Know what's right for selecting medicines, without a doctor visit, that are effective and safe for some everyday health issues - which support brain health.

Keep reading about current standards and resources for you.

Description

Nonprescription medicines, also known as Over-the-Counter (OTC) medicines, can be purchased without a prescription, are safe and effective when you follow the directions on the label.

They are products for treating symptoms and support everyday health like sleep, mood, digestion, pain, sensory function, infection risk, daily functioning.

These relate to health factors within SAFEST BRAINS.

Nonprescription medicines, meeting FDA standards, can appropriately manage some of those factors - examples provided below.

Infant

EXAMPLES

Pain relievers, Fever reducers, Cough suppressants, Decongestants, Saline nasal drops, Diaper rash cream

NOTE

Recommend doctor consultation

Childhood-Adolescence

Adulthood

Elderly

EXAMPLES

Toothpaste, Pain relievers, Fever reducers, Allergy relief, Cough Suppressants, Digestion-related conditions, Dental care, Eye drops, Ear drops, Infections, Sleep aids,, Smoking cessation, Overdose treatment, Weight control, Birth control

NOTE

- Consider doctor consultation for children

- Discuss all OTC drugs with doctor during annual checkups

- Keep all medicines out of reach for infants, children, pets

Environmental protection

Sunscreen, Bug spray, Hand sanitizer, Disinfectant, Antiperspirant

Some are regulated along with other federal agencies like EPA, CDC

FDA Does

Review scientific nonclinical and clinical data to ensure efficacy, safety and product quality (manufacturing, testing, packaging, transporting)

Require products to be tested for:
- 'Label Comprehension' for consumer to understand the label
- 'Self-Selection' for consumer to correctly apply label information to personal medical situations and make correct use decision

Set requirements for certain products under 'Monograph' or for 'switching' from prescription to nonprescription or for 'Additional Conditions for Nonprescription Use (ACNU)'

Monitor post-marketing reports of safety, quality, false promotion and take appropriate action

General Benefit-Risk of Nonprescription Drugs

Benefits

Easy purchase without a prescription
Overcome other challenges such as taking time off work, school for doctor appointments, limited health insurance, not having a healthcare provider, stigma
FDA standards for efficacy, safety, quality and monitored post-marketing
Can be affordable

Risks

Not fully reading, understanding the label (Label comprehension)
Incorrect understanding of appropriateness of drug for medical condition (Self-selection)
Incorrect dosing
Possible side effects
Limitations of use in certain populations like pregnancy, nursing, infants/children, having liver, kidney disease
Potential interactions with other prescription/nonprescription drugs, supplements, medical devices

Expected BENEFITS are greater than RISKS for FDA marketing authorization

Make the right DECISION

Get the full BENEFITS

Reduce your RISKS

BEFORE you purchase

1

Read Label on package

ACTIVE INGREDIENTS: therapeutic substances in medicine, dose
USE: symptoms or diseases the product will treat or prevent
WARNINGS: when not to use the product, when to stop taking it, when to see a doctor, possible side effects, interactions with other drugs
DIRECTIONS: how much to take, how to take it, how long to take it, other conditions (like empty stomach)
OTHER INFORMATION: such as storage information
INACTIVE INGREDIENTS: substances such as binders, colors, or flavoring

2

Self-Select

Check your health history, symptoms, health condition - do the Label Purpose and Uses match these?
Do you understand the Safety sections such Contraindications, Warning, Side effects in context of your medical condition?
Do you understand the restrictions in context of your medical condition?
Can you exactly follow dosing directions, storage conditions?
Do you think your condition is better managed by talking to doctor and taking a prescription drug?

3

Check Expiration Date, Packaging

Understand the need to follow labeled storage conditions
Packaging should not be damaged, show signs of tampering

AFTER you purchase

1

Follow Directions for Use and Storage

Read directions carefully and completely and follow them exactly.
- Highter dose does not provide faster relief, can be a safety concern
Pay attention to special use directions
- Time of day
- How many times/day
- With or without food, avoiding certain food/drink
- What to do if you miss a dose
- When you need to stop taking
Special needs for children - age or weight based dosing
Store as recommended, check expiration date
Don't take medicines in the dark
Check exact measurement (for liquids)
Don't take if discolored or product looks different in any way

2

Recognize Safety Events

Read all Safety information such as Contraindications, Warnings, Side effects
Save these as a reference and re-read often to remember
Understand
- Seriousness of warnings
- Possible side effects
- Possible drug, food interactions
Be on the watch for safety events that match the label and stop taking product
Call doctor or 911 if serious

3

Understand Limitations

Children - dosage is weight-based, age-specific contraindications
Pregnancy and Breastfeeding - drugs may cross placenta or enter breast milk
Older Adults - polypharmacy, cognitive or vision impairments
Chronic Conditions - kidney, liver, cardiovascular disease, diabetes, or hypertension

4

Understand Interactions

Duplicate active ingredients with other medications
Drug-drug interactions
Drug-disease interactions
Drag-food interactions
Drug-alcohol interactions
Situations requiring consultation with healthcare professional

5

Check for Clear Labeling and Claims That Don’t Overpromise

Readable font size, appropriate headings, spacing
Drug Facts Label clearly organized
Clear safety information
Active ingredient clearly indicated
Listing of other ingredients
If label is unclear, check with pharmacist or healthcare provider
If claims are misleading, overpromising, or leaves out important facts - report to FDA, FTC

6

See A Doctor

For Infants, children
Symptoms persist, worsen, recur
Suggest something that cannot safely be self-managed

Convenience & Cost

Purchase from pharmacy, retail, online settings, grocery stores, convenience stores
- See resources below for online pharmacies

Some health plans provide coverage with a prescription from a healthcare provider

Out-of-pocket costs can be affordable
- Avoid high prices of prescription drugs
- Bypass doctor appointment
- Easy and quick availability lowers missed workdays
- Online purchase avoids time and travel limitations