Allergy Acetaminophen and Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN 44;518 Uses temporarily relieves: runny nose sneezing itching of the nose or throat and itchy, watery eyes due to hay fever headache minor aches and pains

Allergy Acetaminophen and Diphenhydramine HCl ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARNAUBA WAX STARCH, CORN CROSCARMELLOSE SODIUM CROSPOVIDONE FD&C YELLOW NO. 6 D&C YELLOW NO. 10 HYPROMELLOSES MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYDEXTROSE POLYETHYLENE GLYCOLS POVIDONES SILICON DIOXIDE STEARIC ACID TITANIUM DIOXIDE TRIACETIN 44;518

Mfr: OTC
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Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 12.5 mg
Inactive Ingredients
Inactive ingredients 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
Strengths
500 mg 12.5 mg
Treats Conditions
Uses Temporarily Relieves Runny Nose Sneezing Itching Of The Nose Or Throat And Itchy Watery Eyes Due To Hay Fever Headache Minor Aches And Pains

Identifiers & Packaging

Container Type BOX
Packaging

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 Fred's 44-518 Fred's 44-518

Package Descriptions
  • 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 Fred's 44-518 Fred's 44-518

Overview

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

Indications & Usage

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

Dosage & Administration

Directions 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

Warnings & Precautions
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 Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product 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 Stop use and ask a doctor if 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. 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 for children even if you do not notice any signs or symptoms.
Purpose

Purpose Pain Reliever Antihistamine

Do Not Use

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

When Using

When using this product 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

Stop Use & Ask a Doctor

Stop use and ask a doctor if 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.

Keep Out of Reach of Children

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.


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