OTC Medication Information: Assured Headache PM (Aspirin Free)

ASSURED HEADACHE PM (ASPIRIN FREE)- acetaminophen and diphenhydramine citrate tablet, coated
Spirit Pharmaceutical LLC

Drug Facts

Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine citrate 38 mg Nighttime sleep-aid

Uses

for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Warnings

Liver warning

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

  • more than 2 caplets in 24 hours, which is the maximum daily amount
  • 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 or general allergic reaction occurs, stop use and seek medical help right away.

Do not use

  • 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 pharmacist.
  • with any other product containing diphenhydramine, even one used on skin
  • in children under 12 years of age

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

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

When using this product

  • avoid alcoholic drinks
  • drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

  • any new symptoms occur
  • sleeplessness lasts continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
  • pain gets worse or lasts more than 10 days
  • painful area is red or swollen
  • fever gets worse or lasts more than 3 days

If pregnant or breast-feeding , ask a health professional before use.

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center 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

  • do not use more than directed
  • do not use in children under 12 years of age
  • adults and children 12 years of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor

Other information

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • read all product information before using. Keep this box for important information.

Inactive ingredients

colloidal silicon dioxide, FD&C Blue # 1, FD&C blue #2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized corn starch, stearic acid, titanium dioxide

Questions or comments?

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PRINCIPAL DISPLAY PANEL

Headache PM
Acetaminophen 500 mg — Pain Reliever
Diphenhydramine Citrate 38 mg — Nighttime Sleep-aid
Aspirin Free

Non habit forming


20 Caplets

Label
(click image for full-size original)
Carton
(click image for full-size original)
ASSURED HEADACHE PM (ASPIRIN FREE)
acetaminophen and diphenhydramine citrate tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-4135
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
DIPHENHYDRAMINE CITRATE (DIPHENHYDRAMINE) DIPHENHYDRAMINE CITRATE 38 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
STARCH, CORN
STEARIC ACID
TITANIUM DIOXIDE
SILICON DIOXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code S26
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68210-4135-2 1 BOTTLE in 1 CARTON contains a BOTTLE
1 20 TABLET, COATED in 1 BOTTLE This package is contained within the CARTON (68210-4135-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 04/28/2021
Labeler — Spirit Pharmaceutical LLC (179621011)

Revised: 12/2023 Spirit Pharmaceutical LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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