Multi-symptom Severe Cold Honey Lemon Flavor 6 Packets

SPL v1

SPL

SPL Set ID a8d73098-aa20-485f-8942-2d9f56fd7887

Route

ORAL

Published

Effective Date 2023-07-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg)

Inactive Ingredients

Anhydrous Citric Acid Caramel Maltodextrin Potassium Chloride Silicon Dioxide Sucralose Sucrose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2023-07-03

Description

Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever / fever reducer Cough Suppressant Nasal Decongestant

Medication Information

Purpose

Pain reliever / fever reducer Cough Suppressant Nasal Decongestant

Description

Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 mg

Uses

▪
temporarily relieves these symptoms due to a cold:
▪
minor aches and pains

Purposes

Pain reliever / fever reducer

Cough Suppressant

Nasal Decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

▪
more than 4,000 mg of acetaminophen in 24 hours
▪
with other drugs containing acetaminophen
▪
3 or more alcoholic drinks every day while using this product

Allergy alert: 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Directions

▪
do not use more than directed
▪
take every 4 hours, while symptoms persist .do not take more than 6 packets in 24 hours unless directed by a doctor

Age	Dose
Adults and children 12 years of age and over	One packet
Children under 12 years of age	Do not use

▪
dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
▪
if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Do Not Use

▪
in a child under 12 years of age
▪
if you are allergic to acetaminophen
▪
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
▪
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

Other Information

▪
each packet contains: potassium 6 mg
▪
Aspartame free, sodium free
▪
store at room temperature. Protect from excessive heat and moisture.

Principal Display

Compare to the active ingredients in Theraflu Multi-Symptom Severe Cold*

NDC 55319-547-06

MULTI-SYMPTOM

SEVERE COLD

Acetaminophen

Pain Reliever/ Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Dye Free

Relieves

•
cough
•
Nasal congestion
•
Sore throat pain
•
Headache
•
Body ache
•
Fever

Honey Lemon

6 PACKETS

TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Severe Cold.

Inactive Ingredients

citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

Questions Or Comments

1-866-467-2748

When Using This Product

do not exceed recommended dosage

Stop Use and Ask A Doctor If

▪
nervousness, dizziness, or sleeplessness occurs
▪
fever gets worse or lasts more than 3 days
▪
redness or swelling is present
▪
new symptoms occur
▪
pain, cough or nasal congestion gets worse or lasts more than 7 days
▪
cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health care professional before use.

Keep Out of Reach of Children.

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

Active Ingredients (in Each Packet)

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Ask A Doctor Before Use If You Have

▪
liver disease
▪
heart disease
▪
high blood pressure
▪
thyroid disease
▪
diabetes
▪
trouble urinating due to an enlarged prostate gland
▪
cough that occurs with too much phlegm (mucus)
▪
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Structured Label Content

Uses

▪
temporarily relieves these symptoms due to a cold:
▪
minor aches and pains

Purposes

Pain reliever / fever reducer

Cough Suppressant

Nasal Decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

▪
more than 4,000 mg of acetaminophen in 24 hours
▪
with other drugs containing acetaminophen
▪
3 or more alcoholic drinks every day while using this product

Allergy alert: 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Directions

▪
do not use more than directed
▪
take every 4 hours, while symptoms persist .do not take more than 6 packets in 24 hours unless directed by a doctor

Age	Dose
Adults and children 12 years of age and over	One packet
Children under 12 years of age	Do not use

▪
dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes.
▪
if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.

Do Not Use (Do not use)

▪
in a child under 12 years of age
▪
if you are allergic to acetaminophen
▪
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
▪
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

Other Information (Other information)

▪
each packet contains: potassium 6 mg
▪
Aspartame free, sodium free
▪
store at room temperature. Protect from excessive heat and moisture.

Principal Display

Compare to the active ingredients in Theraflu Multi-Symptom Severe Cold*

NDC 55319-547-06

MULTI-SYMPTOM

SEVERE COLD

Acetaminophen

Pain Reliever/ Fever Reducer

Dextromethorphan HBr

Cough Suppressant

Phenylephrine HCl

Nasal Decongestant

Dye Free

Relieves

•
cough
•
Nasal congestion
•
Sore throat pain
•
Headache
•
Body ache
•
Fever

Honey Lemon

6 PACKETS

TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN.

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Severe Cold.

Inactive Ingredients (Inactive ingredients)

citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,

Questions Or Comments (Questions or Comments)

1-866-467-2748

When Using This Product (When using this product)

do not exceed recommended dosage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

▪
nervousness, dizziness, or sleeplessness occurs
▪
fever gets worse or lasts more than 3 days
▪
redness or swelling is present
▪
new symptoms occur
▪
pain, cough or nasal congestion gets worse or lasts more than 7 days
▪
cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health care professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each Packet) (Active ingredients (in each packet))

Acetaminophen 500 mg

Dextromethorphan hydrobromide 20 mg

Phenylephrine hydrochloride 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

▪
liver disease
▪
heart disease
▪
high blood pressure
▪
thyroid disease
▪
diabetes
▪
trouble urinating due to an enlarged prostate gland
▪
cough that occurs with too much phlegm (mucus)
▪
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "▪ temporarily relieves these symptoms due to a cold: ▪ minor aches and pains", "Purposes": "Pain reliever / fever reducer Cough Suppressant Nasal Decongestant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ▪ more than 4,000 mg of acetaminophen in 24 hours ▪ with other drugs containing acetaminophen ▪ 3 or more alcoholic drinks every day while using this product Allergy alert: 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 Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.", "Directions": "▪ do not use more than directed ▪ take every 4 hours, while symptoms persist .do not take more than 6 packets in 24 hours unless directed by a doctor Age Dose Adults and children 12 years of age and over One packet Children under 12 years of age Do not use ▪ dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10 - 15 minutes. ▪ if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating, Do not overheat.", "Do not use": "▪ in a child under 12 years of age ▪ if you are allergic to acetaminophen ▪ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist. ▪ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.", "Other information": "▪ each packet contains : potassium 6 mg ▪ Aspartame free, sodium free ▪ store at room temperature. Protect from excessive heat and moisture.", "Principal Display": "Compare to the active ingredients in Theraflu Multi-Symptom Severe Cold* NDC 55319-547-06 MULTI-SYMPTOM SEVERE COLD Acetaminophen Pain Reliever/ Fever Reducer Dextromethorphan HBr Cough Suppressant Phenylephrine HCl Nasal Decongestant Dye Free Relieves • cough • Nasal congestion • Sore throat pain • Headache • Body ache • Fever Honey Lemon 6 PACKETS TAMPER EVIDENT INNER UNIT: DO NOT USE IF SEALED PACKET IS TORN OR BROKEN. *This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Multi-Symptom Severe Cold.", "Inactive ingredients": "citric acid, caramel, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose,", "Questions or Comments": "1-866-467-2748", "When using this product": "do not exceed recommended dosage", "Stop use and ask a doctor if": "▪ nervousness, dizziness, or sleeplessness occurs ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ pain, cough or nasal congestion gets worse or lasts more than 7 days ▪ cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.", "If pregnant or breast-feeding,": "ask a health care professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Active ingredients (in each packet)": "Acetaminophen 500 mg Dextromethorphan hydrobromide 20 mg Phenylephrine hydrochloride 10 mg", "Ask a doctor before use if you have": "▪ liver disease ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ trouble urinating due to an enlarged prostate gland ▪ cough that occurs with too much phlegm (mucus) ▪ cough that lasts or is chronic such as occurs with smoking, asthma or emphysema", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:02.236745 · Updated: 2026-03-14T23:01:14.422395