Drug Facts

Active ingredients (in each caplet)                                             Purposes

Acetaminophen 500 mg                                                              Pain reliever

Diphenhydramine HCl 25 mg                                                           Sleep aid

Uses    temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Warnings
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use    œ with any other products containing acetaminophen or diphenhydramine, even one used on skin

œ in children under 12 years of age

Ask a doctor before use if you have

œ a breathing problem such as emphysema or chronic bronchitis

œ trouble urinating due to an enlarged prostate gland

œ glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

œ drowsiness will occur

œ avoid alcoholic drinks

œ do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if    œ sleeplessness persists continuously for more than 2 weeks.  Insomnia may be a symptom of serious underlying medical illness.

œ new symptoms occur

œ redness or swelling is present

œ pain gets worse or lasts more than 10 days

œ fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

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

Keep out of reach of children. 

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. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions    œ do not take more than directed (see overdose warning)

œ adults and children 12 years and over:  take 2 caplets at bedtime or as directed by a doctor

œ children under 12 years of age:  do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems

Other information    œ each caplet contains:  4 mg of sodium

œ do not use if printed seal under cap is missing or damaged   

œ store at room temperature   

Inactive ingredients    colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, FD&C blue #2, hypromellose, maltodextrin, microcrystalline cellulose, medium chain triglycerides, polydextrose, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide