Label: PAMPRIN MAX MENSTRUAL PAIN RELIEF- acetaminophen and aspirin and caffeine tablet, film coated
- NDC Code(s): 71687-3006-6
- Packager: Focus Consumer Healthcare, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 12, 2023
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- Official Label (Printer Friendly)
- PURPOSE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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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
- feel faint
- 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
- hives
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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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAMPRIN MAX MENSTRUAL PAIN RELIEF
acetaminophen and aspirin and caffeine tablet, film coatedProduct 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) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) 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 Drug M013 10/18/2017 Labeler - Focus Consumer Healthcare, LLC (080743737)
