SPL v1
SPL
SPL Set ID af69d604-180c-702f-e053-2a95a90a2ae4
Route
ORAL
Published
Effective Date 2020-09-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tangerine (1 g) Acetaminophen (0.06 g) Saposhnikovia Divaricata Root (0.00425 g) Dextromethorphan
Inactive Ingredients
Lactose Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-09-16

Description

Citrus Unshiu Peel(KP) Saposhnikovia Root(KP) Acetaminophen Dextromethorphan Hydrobromide


Medication Information

Warnings and Precautions

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Indications and Usage

for adults take 1 pouch per intake, 3 times a day, before or between meals

Dosage and Administration

For oral use only

Description

Citrus Unshiu Peel(KP) Saposhnikovia Root(KP) Acetaminophen Dextromethorphan Hydrobromide

Section 50565-1

Keep out of reach of children

Section 51727-6

Atractylodes Rhizome(KP), Aurantium lmmature Fruit(KHP), Perilla Leaf(KP), Poria(KP)

Platycodon Root(KP), Cnidium Rhizome(KP), Bupleurum Root(KP), Pueraria Root(KP)

Schizonepeta Spike(KP), Angelica Decursiva Root(KHP), Ostericum Root(KP)

Section 51945-4

Section 55105-1

minor aches and pain from colds, headache fever

Section 55106-9

Citrus Unshiu Peel(KP)

Saposhnikovia Root(KP)

Acetaminophen

Dextromethorphan Hydrobromide


Structured Label Content

Indications and Usage (34067-9)

for adults take 1 pouch per intake, 3 times a day, before or between meals

Dosage and Administration (34068-7)

For oral use only

Warnings and Precautions (34071-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Atractylodes Rhizome(KP), Aurantium lmmature Fruit(KHP), Perilla Leaf(KP), Poria(KP)

Platycodon Root(KP), Cnidium Rhizome(KP), Bupleurum Root(KP), Pueraria Root(KP)

Schizonepeta Spike(KP), Angelica Decursiva Root(KHP), Ostericum Root(KP)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

minor aches and pain from colds, headache fever

Section 55106-9 (55106-9)

Citrus Unshiu Peel(KP)

Saposhnikovia Root(KP)

Acetaminophen

Dextromethorphan Hydrobromide


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)