Allergy

FRED'S, INC.

Freds 44-518

FULL PRESCRIBING INFORMATION: CONTENTS*

• Warnings
  • Do not use
  • Keep out of reach of children.
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Acetaminophen 500 mg
Diphenhydramine HCl 12.5 mg 

Pain Reliever
Antihistamine

temporarily relieves:

• runny nose
• sneezing
• itching of the nose or throat and itchy, watery eyes due to hay fever
• headache
• minor aches and pains 

Warnings

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

• more than 8 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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.
• with any other product containing diphenhydramine, even one used on skin

• liver disease
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• trouble urinating due to an enlarged prostate gland

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

• new symptoms occur
• pain gets worse or lasts more than 10 days
• pain gets worse or lasts more than 3 days
• redness or swelling is present

These could be signs of a serious condition. 

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 for children even if you do not notice any signs or symptoms.

• do not take more than directed
  (see overdose warning  )
• adults and children 12 years and over
  • take 2 caplets every 4 to 6 hours
  • do not take more than 8 caplets 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

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

carnauba wax, corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

Principal Display Panel

FRED'S_®

Severe
Allergy
Pain Reliever/Antihistamine

Sinus Pain - Acetaminophen
Itchy, Watery Eyes
Runny Nose
Sneezing - Diphenhyrdamine HCl
Pseudoephedrine Free            

24 Coated Caplets

Compare to the active ingredients in:
Tylenol® Severe Allergy*

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Severe Allergy.
50844      REV0612D51808