PAIN AND FEVER- acetaminophen tablet

Pain and Fever by

Drug Labeling and Warnings

Pain and Fever by is a Otc medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Acetaminophen 325 mg

PURPOSE

Purposes

Pain reliever/fever reducer

INDICATIONS & USAGE

Uses

• for the temporary relief of minor aches and pains due to:
• headache
• muscular aches
• backache
• minor pain of arthritis
• the common cold
• toothache
• premenstrual and menstrual cramps
• temporarily reduces fever
  

WARNINGS

Warnings

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

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product
  

Ask a doctor before use if the user has liver disease

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Stop use and ask a doctor if

• pain gets worse or lasts more than 10 days in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

do not take more than directed (see overdose warning)

• adults and children 12 years and over:
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 10 tablets in 24 hours. unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
• children 6 years to under 12 years:
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
• children under 6 years: ask a doctor

STORAGE AND HANDLING

Other information store at room temperature

INACTIVE INGREDIENT

Inactive ingredients povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid

QUESTIONS

Questions or comments? 1-800-645-2158

OTHER SAFETY INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed By: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

PRINCIPAL DISPLAY PANEL

DRUG: Pain and Fever

GENERIC: ACETAMINOPHEN

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0983-0

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: GPIA325

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• ACETAMINOPHEN 325mg in 1

INACTIVE INGREDIENT(S):

• POVIDONE
• SODIUM STARCH GLYCOLATE TYPE A POTATO
• STARCH, CORN
• STEARIC ACID

INGREDIENTS AND APPEARANCE

PAIN AND FEVER 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70518-0983(NDC:0536-3222)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (flat faced beveled edge)	Size	10mm
Flavor		Imprint Code	GPIA325
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-0983-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	01/22/2018

Labeler - REMEDYREPACK INC. (829572556)