PAMPRIN MAX MENSTRUAL PAIN RELIEF- acetaminophen and aspirin and caffeine tablet, film coated

Pamprin Max Menstrual Pain Relief by

Drug Labeling and Warnings

Pamprin Max Menstrual Pain Relief by is a Otc medication manufactured, distributed, or labeled by Focus Consumer Healthcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Pain reliever

Diuretic

*nonsteroidal anti-inflammatory drug

ACTIVE INGREDIENT

(in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg

INACTIVE INGREDIENT

D&C Red No. 27 Lake, FD&C Red No. 40 Lake, fractionated coconut oil, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide (245-171)

INDICATIONS & USAGE

For the temporary relief of these symptoms associated with menstrual periods:

• cramps
  
• headache
  
• backache
  
• fatigue
  
• bloating

WARNINGS

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

• hives
  
• facial swelling
  
• asthma (wheezing)
  
• shock

Allergy warning: 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.

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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

• are age 60 or older
  
• have had stomach ulcers or bleeding problems
  
• take a blood thinning (anticoagulant) or steroid drug
  
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  
• have 3 or more alcoholic drinks every day while using this product
  
• take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

• you have liver disease
  
• the stomach bleeding warning applies to you
  
• you have a history of stomach problems, such as heartburn
  
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  
• you are taking a diuretic

Ask a doctor or pharmacist before use

if you are taking a prescription drug for gout, diabetes or arthritis

Stop use and ask a doctor if

• an allergic reaction occurs. Seek medical help right away.
  
• you experience any of the following signs of stomach bleeding:
  • feel faint
    
  • vomit blood
    
  • have bloody or black stools
    
  • have stomach pain that does not get better

• redness or swelling is present
  
• new symptoms occur
  
• pain gets worse or lasts more than 10 days
  
• fever gets worse or lasts more than 3 days
  
• ringing in the ears or loss of hearing occurs

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

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.

SPL UNCLASSIFIED SECTION

When using this product

• you may get drowsy, avoid alcoholic beverages
• alcohol sedatives and tranquilizers may increase drowsiness
• use caution when driving or operating machinery
• excitability may occur especially in children

stop use and ask doctor if

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

If pregnant or breastfeeding, 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Adults and children12 years and over:

take 2 caplets with water every 6 hours as needed

do not exceed 8 caplets in a 24 hour period or as directed by a doctor

do not use more than directed (see warnings)

children under 12 years: ask a doctor

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAMPRIN MAX MENSTRUAL PAIN RELIEF 
acetaminophen and aspirin and caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71687-3006
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	pink (FD & C Red No. 40) , pink (D&C REd No. 27)	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	MAX
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71687-3006-6	1 in 1 CARTON	10/18/2017
1		24 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	10/18/2017

Labeler - Focus Consumer Healthcare, LLC (080743737)