af69d604-180c-702f-e053-2a95a90a2ae4

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.

Active Ingredient

Citrus Unshiu Peel(KP)

Saposhnikovia Root(KP)

Acetaminophen

Dextromethorphan Hydrobromide

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

Structured Label Content

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.

Active Ingredient (55106-9)

Citrus Unshiu Peel(KP)

Saposhnikovia Root(KP)

Acetaminophen

Dextromethorphan Hydrobromide

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

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

Advanced Ingredient Data

[{"name": "TANGERINE", "unii": "KH3E3096OO", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "3", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "0.06", "strengthDenominator": "3", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SAPOSHNIKOVIA DIVARICATA ROOT", "unii": "8H84LFK2QD", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "3", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "0.00425", "strengthDenominator": "3", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "for adults take 1 pouch per intake, 3 times a day, before or between meals", "34068-7": "For oral use only", "34071-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50565-1": "Keep out of reach of children", "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)", "55105-1": "minor aches and pain from colds, headache fever", "55106-9": "Citrus Unshiu Peel(KP) Saposhnikovia Root(KP) Acetaminophen Dextromethorphan Hydrobromide"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:44.813802 · Updated: 2026-03-14T22:58:28.205910