PAIN AND FEVER- acetaminophen tablet, chewable

Pain and Fever by

Drug Labeling and Warnings

Pain and Fever by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES, Gemini Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

PURPOSE

Purposes

Pain Reliever/Fever Reducer

INDICATIONS & USAGE

Uses

• temporarily relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache
• temporarily reduces fever.

WARNINGS

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• with any other other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease.

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product,do not exceed recommended dose (see overdose warning).

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800- 222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• this product does not contain directions or warnings for adult use.
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• chew before swallowing
• if needed, repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed by a doctor

Weight	Age	Dosage
Under 24 lbs	Under 2 years	Ask a doctor
24-35 lbs	2-3 years	2 tablets
36-47 lbs	4-5 years	3 tablets
48-59 lbs	6-8 years	4 tablets
60-71 lbs	9-10 years	5 tablets
72-95 lbs	11 years	6 tablets

STORAGE AND HANDLING

Other information

• Phenylketonurics: Contains Phenylalanine 14 mg per tablet
• Store at room temperature in a dry place

INACTIVE INGREDIENT

Inactive ingredients Aspartame, Colloidal Silicon Dioxide, D&C Red #27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural and Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

QUESTIONS

Questions or comments?

Call 1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

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

PRINCIPAL DISPLAY PANEL

Rugby®

See New Warnings Information

NDC: 0536-1014-07

RELIEVES CHILDREN'S

Pain and Fever

WITHOUT ASPIRIN

Acetaminophen, 80 mg EACH

NATURAL & ARTIFICIAL BERRY FLAVORS

30 CHEWABLE TABLETS

AGES 2-11

INGREDIENTS AND APPEARANCE

PAIN AND FEVER 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	80 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
D&C RED NO. 27 (UNII: 2LRS185U6K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND (ROUND BICONVEX TABLET)	Size	10mm
Flavor	BERRY (Natural and Artificial)	Imprint Code	1G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1014-07	1 in 1 CARTON	12/01/2013	05/31/2021
1		30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/01/2013	05/31/2021

Labeler - RUGBY LABORATORIES (079246066)

Registrant - Gemini Pharmaceuticals, Inc. (055942270)

Establishment
Name	Address	ID/FEI	Business Operations
Gemini Pharmaceuticals, Inc.		055942270	manufacture(0536-1014)