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Period Pills by Biikay

Approved
Approval ID

3ddb67cf-3af8-653d-e063-6294a90ab641

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Kai Squared

DUNS: 130976767

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

acetaminophen, ibuprofen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85576-112
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
acetaminophen, ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (13)

ACETAMINOPHENActive
Quantity: 250 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
IBUPROFENActive
Quantity: 125 mg in 1 1
Code: WK2XYI10QM
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/1/2025

PDP and pill image

Period Pills

by Biikay

Pain Reliever

Acetaminophen 250 mg

Ibuproften (NSAID) 125 mg Image of pill

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/1/2025

Uses:

Temporarily relieves minor aches and pains due to: headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/1/2025

Directions:

  • Do not take more than directed
  • Adults and children 12 years and over
  • Take 2 caplets every 8 hours while symptoms persist
  • Children under 12 years ask a doctor
  • Do not take more than 6 caplets in 24 hours, unless directed by a doctor

WARNINGS SECTION

LOINC: 34071-1Updated: 12/1/2025

Warnings

Acetaminophen liver damage warning: This product contains acetaminophen. Severe liver damage may occur if you take: with other drugs containing acetaminophen, more than 6 caplets in 24 hours, which is the maximum daily amount for this product, 3 or more alcoholic drinks every day while using this product.

Acetaminophen allergy alert: may cause severe skin reactions. Symptoms include, skin reddening, blisters, rash.
If skin reactions occurs, stop use and seek medical help right away.

NSAID allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include: hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, blisters
If an allergic reaction occurs, stop use and seek medical help right away.

NSAID stomach bleeding warnings: 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.

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

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 have ever had an allergic reaction to acetaminophen or any other pain reliever, right before or after heart surgery.

Ask a doctor before use if:

You have liver disease, stomach bleeding warning applies to you, you have problems or serious side effects from taking pain relievers, you have a history of stomach problems such as heartburn, you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke, you are taking a diuretic.

Ask a doctor or pharmacist before use if you are:

Under a doctor’s care for any serious condition, taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin, taking any other drug.

When using this product, take with food or milk if stomach upset occurs.

Stop use and ask a doctor if, 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, you have symptoms of heart problems or stroke: chest pain, trouble breathing, weakness in one part or side of body, slurred speech, leg swelling, pain gets worse or lasts more than 10 days, redness or swelling is present in the painful area, any new symptoms appear.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 12/1/2025

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in 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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/1/2025

Uses:

Temporarily relieves minor aches and pains due to:

headache, toothache, backache, menstrual cramps, muscular aches, minor pain of arthritis

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/1/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/1/2025

Inactive ingredients:

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, crospovidone, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid and titanium dioxide.

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Period Pills by Biikay - FDA Drug Approval Details