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FDA LABEL GENERIC: Acetaminophen MFR: Allegiant Health

1 Daytime (acetaminophen 325 Mg / Dextromethorphan Hbr 10 Mg Oral Capsule) / 1 Nighttime (acetaminophen 325 Mg / Dextromethorphan Hbr 15 Mg / Doxylamine Succinate 6.25 Mg Oral Capsule) Pack

Active ingredient(s)

DAYTIME ONLY

Acetaminophen 325mg

Dextromethorphan HBr 10mg

NIGHTTIME ONLY

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

Purpose

DAYTIME ONLY

Pain reliever/fever reducer

Cough suppressant

NIGHTTIME ONLY

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Use(s)

DAYTIME ONLY

temporarily relieves these symptoms due to a cold or flu:

cough sore throat headache minor aches and pains temporarily reduces fever

NIGHTTIME ONLY

temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation

• sore throat

• headache

• minor aches & pains

• fever

• runny nose & sneezing

Warnings

DAYTIME

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

more than 10 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

NIGHTTIME

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 4 doses in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

DAYTIME AND NIGHTTIME

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,
occurs with or is followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.

Do not use if you have

DAYTIME ONLY

• 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 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 an MAOI, ask a
doctor or pharmacist before taking this product.

if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age

NIGHTTIME ONLY

• 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 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 an MAOI, ask a doctor or pharmacist before taking this product.
• to make a child sleep

Ask a doctor before use if you

DAYTIME ONLY

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

NIGHTTIME ONLY

• liver disease •glaucoma • cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking,
  asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if

DAYTIME ONLY

taking the blood thinning drug warfarin.

NIGHTTIME ONLY

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

DAYTIME ONLY

do not exceed recommended dosage.

NIGHTTIME ONLY

• do not use more than directed
• excitability may occur, especially in children
• marked drowsiness may occur • avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives & tranquilizers may increase drowsiness

Stop use and ask a doctor if

DAYTIME ONLY

Stop use and ask a doctor if

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

NIGHTTIME ONLY

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

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
(1-800-222-1222) right away. Quick medical attention is critical
for adults as well as for children, even if you do not notice any signs or symptoms.

Directions

DAYTIME ONLY

Take only as directed Do not exceed 4 doses in 24hours

Adults and children 12 yrs & over: 2 softgels with water every 4 hrs

Children under 12 yrs: ask a doctor

Children under 4 yrs: do not use

NIGHTTIME ONLY

Take only as directed Do not exceed 4 doses in 24hours

Adults and children 12 yrs & over: 2 softgels with water every 6 hrs

Children 4 to under 12 yrs: ask a doctor

Children under 4 yrs: do not use

Other information

store at room temperature 20-25 °C (68-77° F) Avoid excessive heat do not use if blister unit is torn or open

Inactive ingredients

DAYTIME ONLY

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol 400, Povidone K12, Propylene Glycol, Purified
water, Sorbitol Sorbitan Solution, White Edible Ink

NIGHTTIME ONLY

D&C Yellow #10, FD&C Blue #1, Gelatin, Glycerin, Polyethylene Glycol, Povidone, Propylene
Glycol, Purified Water, Sorbitol Sorbitan Solution, White Edible Ink

Questions/Comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

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